Noticias sobre Spherium

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  • 17 DE MAYO DEL 2018

    NOTA DE PRENSA

    MUCOMEL® DE SPHERIUM, EFICAZ PARA LA MUCOSITIS EN PACIENTES DE CÁNCER DE CABEZA Y CUELLO

    La biofarmacéutica consigue resultados positivos en el ensayo clínico de fase II
    Se presentarán en la reunión anual de la American Society of Clinical...

  • 26 DE ABRIL DEL 2018

    Mucomel® Phase II results selected to be presented at ASCO

    • Spherium Biomed announced today the completion of its Phase I/IIa clinical trial of Mucomel®, for the prevention and treatment of oral mucositis in head and neck cancer patients undergoing chemo-radiotherapy.

    • The trial was designed...

  • 12 DE ABRIL DEL 2018

    Maribel Berges, new vice-president of the board at CataloniaBio & Health Tech

    The Catalan association of companies in the biomedicine and health arena, CataloniaBio & HealthTech, has just chosen its new board for the 2018-2022 period. Maribel Berges, co-founder and managing partner at Spherium Biomed, has been elected...

17 DE MAYO DEL 2018

NOTA DE PRENSA

MUCOMEL® DE SPHERIUM, EFICAZ PARA LA MUCOSITIS EN PACIENTES DE CÁNCER DE CABEZA Y CUELLO

La biofarmacéutica consigue resultados positivos en el ensayo clínico de fase II
Se presentarán en la reunión anual de la American Society of Clinical Oncology (ASCO 2018), el próximo junio en Chicago

Barcelona, 17 de mayo de 2018. Spherium Biomed, compañía biofarmacéutica con sede en Barcelona, anuncia que ha obtenido resultados positivos con su nuevo fármaco Mucomel® en un ensayo clínico de fase I/IIa para la prevención y tratamiento de la mucositis oral en pacientes de cáncer de cabeza y cuello tratados con quimio y radioterapia. En el estudio, controlado por placebo, han participado 84 pacientes de 10 hospitales de toda España.
Se ha demostrado que Mucomel® reduce la incidencia de mucositis severa casi a la mitad de los pacientes. Además, en los pacientes que desarrollan mucositis, su duración se acorta con una reducción considerada clínicamente muy relevante por los médicos que han participado en el estudio.
Los resultados completos del ensayo clínico han sido seleccionados para presentarse en una sesión oral de la reunión anual de la American Society of Clinical Oncology (ASCO) el 3 de junio en Chicago, que irá a cargo de la investigadora principal Dra. Alicia Lozano del Instituto Catalán de Oncología (ICO). El resumen de los resultados puede consultarse en este abstract.
El Dr. Ramon Bosser, COO de Spherium, ha comentado que 'estos resultados nos alientan a continuar con nuestros esfuerzos para hacer que Mucomel® esté disponible para los pacientes de todo el mundo. Nuestro agradecimiento a todos los médicos, enfermeras y pacientes que hicieron posible el ensayo clínico. Ha sido un gran trabajo de equipo'.
Actualmente, Spherium está negociando con socios internacionales el codesarrollo de la fase clínica III del fármaco, que se prevé que esté disponible en el mercado aproximadamente en 2022.
La mucositis puede interrumpir la quimio y radioterapia
Más de 550.000 pacientes en todo el mundo sufren mucositis oral cada año. Esta dolencia provoca úlceras muy dolorosas en toda la cavidad bucal y esófago. Puede aparecer como consecuencia del tratamiento en varios tipos de cáncer, pero es particularmente relevante en cáncer de cabeza y cuello. En estos casos es el efecto secundario más frecuente asociado al tratamiento ya que prácticamente todos los pacientes desarrollan mucositis oral en mayor o menor grado. La forma más severa afecta aproximadamente al 80% de los pacientes, a los que provoca un dolor extremo dificultando o impidiendo la ingestión de sólidos y líquidos. En los casos más graves requiere intubación, hospitalización y hasta interrupción del tratamiento oncológico.
….
Sobre Spherium Biomed
Spherium Biomed (www.spheriumbiomed.com) es una empresa que desarrolla productos biomédicos de origen académico desde sus fases iniciales hasta que alcanzan un punto de inflexión en su desarrollo, normalmente asociado a la primera demostración de su eficacia clínica. La empresa recibió a finales de 2013 una inversión de 15 millones de euros de la farmacéutica Ferrer, con los que ha generado una cartera de 4 productos en fases clínicas y 4 en fases de investigación, todos ellos originados en investigación académica en España, Polonia e Israel. El resultado de Mucomel®, originado en las investigaciones de la Dra. Germaine Escames de la Universidad de Granada y licenciado por Spherium en 2013, supone para la compañía la consolidación de su modelo y la demostración del enorme potencial de la innovación académica en España.
….
Más información:

Spherium Biomed
Gabinete de comunicación (Gemma Escarré)
M. 667 76 15 24
info@gemmaescarre.com / info@spheriumbiomed.com

 

26 DE ABRIL DEL 2018

Mucomel® Phase II results selected to be presented at ASCO

• Spherium Biomed announced today the completion of its Phase I/IIa clinical trial of Mucomel®, for the prevention and treatment of oral mucositis in head and neck cancer patients undergoing chemo-radiotherapy.

• The trial was designed to include 84 patients with advanced disease receiving high dose radiotherapy and concomitant treatment with cisplatin or cetuximab enrolled from 11 hospitals in Spain.

• The results will be presented by the leading investigator, Dr. Alicia Lozano, at the Head and Neck cancer oral abstract session of the ASCO meeting in Chicago on June 3rd.

Barcelona, April 26th, 2018.- Spherium Biomed has completed the analysis of the results of the Mucomel® trial, a phase I/IIb prospective, double blinded and placebo controlled trial to evaluate the safety and efficacy of its high dose melatonin gel, Mucomel®, for the prevention and treatment of oral mucositis (OM) in head and neck cancer patients receiving chemo-radiotherapy (NCT02630004).

The trial aimed to include 84 patients from 11 sites in Spain. The patients were selected among those scheduled to receive high dose radiation (at least 66 Gy) and concomitant cisplatin or cetuximab treatment for 2 months according to standard clinical practices for advanced grade head and neck cancer in Spain. Patients were instructed to use Mucomel® or placebo gels 5 times a day over the full course of the treatment.

The trial’s objectives were to evaluate safety and explore efficacy. The results will be fully disclosed at the oral abstract presentation of the Head & Neck Cancer track of the American Society of Clinical Oncology meeting in Chicago on June 3th according to the final program made public yesterday by the ASCO organizers (Abstract 6007, https://iplanner.asco.org/am2018/#/)

Mucositis is defined as inflammatory and/or ulcerative lesions of the gastrointestinal tract mucosa. Oral mucositis affects the oral mucosa causing erythematous and ulcerative lesions. It is particularly relevant in patients with cancer being treated with chemo- and/or radiation therapy, especially in high dose CT / RT in head and neck cancer patients. Severe oral mucositis leads to pain, changes in diet (including parenteral feeding), hospitalization and de-escalation of oncologic treatment.

There are more than 550.000 cases of Head and Neck cancer every year, and no drug is approved for the treatment or prevention of oral mucositis. The standard of care is based in pain medication and oral rinses or barrier devices to maintain mucosal integrity. Nearly 100% of patients receiving chemo and/or radio therapy will develop OM. 70% to 85% of patients receiving chemo-radio therapy will develop severe OM (Grades 3 or 4). At grade 3, the patients are in excruciating pain and cannot swallow solids; at Grade 4 the patients cannot drink and require feeding-tubes. In addition to head and neck cancer patients, 75% of patients receiving bone marrow transplantation for hematological cancer are expected to develop OM. In other types of cancer, 20-40% of patients receiving standard chemotherapy may also develop OM.


Mucomel® is based on a proprietary, patented high-load gel formulation of melatonin presented in individual 10ml sachets, to facilitate administration on out-patient basis. Spherium aims to partner the program during 2018 to complete development and reach patients worldwide as fast as possible.

 

About Spherium (www.spheriumbiomed.com)

Spherium Biomed is a clinical-stage, biopharmaceutical portfolio company that sources its pipeline from academic research. The company applies a lean, hands-on venture builder model to advance its portfolio up to a relevant value milestone to increase the chance of academic discoveries reaching the market. The company applies its broad experience in drug development (from discovery to clinical and commercial stages) to deeply analyze the commercial potential of technologies. After defining the relevant gaps with respect to an ideal target product profile, the company acquires development and commercialization rights for the asset and derives a creative and cost-effective work plan to bring the project forward, and implements the plan with its own resources and the proactive coordination of external providers.

Spherium is privately owned; its major shareholders are its founders and key executives, and the Spanish pharmaceutical company Ferrer (www.ferrer.com). Its current portfolio includes three Phase II clinical stage projects and one Phase I. The portfolio includes several first-in-class preclinical projects as well, two of them undergoing IND-enabling regulatory safety-toxicology and industrial scaling up. The company is constantly looking for new opportunities addressing unmet clinical needs.

For more information please contact info@spheriumbiomed.com

12 DE ABRIL DEL 2018

Maribel Berges, new vice-president of the board at CataloniaBio & Health Tech

The Catalan association of companies in the biomedicine and health arena, CataloniaBio & HealthTech, has just chosen its new board for the 2018-2022 period. Maribel Berges, co-founder and managing partner at Spherium Biomed, has been elected one of the vice-presidents of this governing body, led by Specipig and Rob Surgical CEO Jaume Amat.

The association currently has more than 150 active members and plays a key role in the Catalan health entrepreneurial ecosystem, promoting R&D to help the business fabric generate new products and services to improve people’s wellbeing.

The most important CataloniaBio & HealthTech networking events are the winter gala dinner, when the Biosuccess Awards recognising ground-breaking deals are announced, and the summer BioBBQ, where executives from the member companies gather to enjoy a unique social event on the splendid grounds of preclinical CRO Specipig. Spherium is in charge of the BioBBQ part of this event: we bring the lambs from Castile and barbecue them Argentinian style, in a 5-hour ‘tour de force’ from our team, to feed more than 250 discerning diners!

“Spherium will maintain its commitment to the progress of the buoyant biomed sector in Catalonia, on both formal (board) and informal (fun BBQ) levels. Both are important,” says Maribel Berges.

Photo: the new CataloniaBio & HealthTech board of directors at the 2018 gala dinner on 8 March in Barcelona

 

  • 8 DE ABRIL DEL 2018

    On disruptive innovation, a tribute to Jorge Wagensberg

    Jorge Wagensberg passed away on March 3rd. He was the artistic director of the future Hermitage Museum in Barcelona. He was one of the most recognized nature museums directors in the world. He pushed the concept of hands-on, interpretative...

  • 12 DE ABRIL DEL 2018

    Veterinarian licensing deal with Simini Technologies, from Canada

    Spherium Biomed has signed a licensing agreement with Simini Technologies from Ontario (Canada) to develop veterinarian applications based on the Spherium’s proprietary topical cyclosporine (SP14019).

    Simini aims to turn cutting-edge science...

  • 12 DE ABRIL DEL 2018

    Cyclatop© for atopic dermatitis heating up!

    In February, Spherium Biomed completed enrolment in the Cyclatop© (SP14019) trial. This phase IIa clinical study in paediatric and adult patients with mild to moderate atopic dermatitis is designed as a proof-of-concept, multi-centre, randomised...

8 DE ABRIL DEL 2018

On disruptive innovation, a tribute to Jorge Wagensberg

Jorge Wagensberg passed away on March 3rd. He was the artistic director of the future Hermitage Museum in Barcelona. He was one of the most recognized nature museums directors in the world. He pushed the concept of hands-on, interpretative science museums to the current standards set by the CosmoCaixa Museum. He was Professor of Physics of Irreversible Processes in the university. He wrote books, many books, and papers, on thermodynamics and microbiology and evolution. He discussed the very concept of evolutionary progress face to face with Stephen Jay Gould. He had a lot of fun explaining the function behind the different shapes of living creatures. He spent time looking for something to expose in his museum which he could label “we don’t have the slightest idea of what this is about”. He was one of the few geniuses you meet in a lifetime, the kind of person that slaps your few active neurons with new ideas, and give you food for thought just upon a minor interaction.
The day after his death I went to a second-hand book fair. Coincidentally, one of the first book I saw was one of his “Más árboles que ramas” (literally “More trees than branches”). I bought it, it is an aphorism book. He liked telling huge ideas in very simple aphorisms (one of my favorites is “Distrust ideas that don’t fit in a single phrase”). The whole book is built around a very simple statement that comes straight from the cover:
“To change the answer is evolution, to change the question is revolution”.
And as usual with him, this simple sentence made me wonder. I immediately thought of innovation, because this is the playground in which my brain operates more comfortably. And I thought in what most of us do for a living, which is development of new drugs to solve unmet medical needs. And I also thought in the way we try to do it at Spherium, going around cherry picking academic discoveries and pushing them forward in the value chain to show they may become someday a useful therapeutic tool. And I thought all this because one of our “selling bullets” when talking about our business model in Spherium is that we don’t have the answers, just a good list of questions. And we recognize that having the right question is far more important than giving an answer.
Answers can change, they evolve with information, regulation, competition or just the trend of a given moment. Changing answers is like providing incremental innovation (evolution in Wagensberg’s statement). But changing a question requires a lot more. Requires thinking out of the box, looking behind, starting from scratch, forgetting past assumptions that are deeply entangled in our brains…
A change in a question is a change in a paradigm, and therefore an opportunity to disruptive innovation. We have a very recent example of this in our portfolio, SP14040. An unexpected set of (very good) preclinical results made as wake up one day wondering “what if we think of this project as a breakthrough third generation antipsychotic with cognition enhancement potential, instead of an improved drug for the management of cognition deficit”. And there you go, a shift in paradigm leading to a completely new Target Product Profile with blockbuster potential.
Take a good rest Jorge Wagensberg, thanks for all the ideas you gave me over the last 35 years, and for new ideas to come just for opening your books or visiting your museums time by time. We at Spherium will keep our eyes open to new questions, just in case.

Luis Ruiz-Ávila, CEO of Spherium Biomed

 

12 DE ABRIL DEL 2018

Veterinarian licensing deal with Simini Technologies, from Canada

Spherium Biomed has signed a licensing agreement with Simini Technologies from Ontario (Canada) to develop veterinarian applications based on the Spherium’s proprietary topical cyclosporine (SP14019).

Simini aims to turn cutting-edge science from human health into effective new pharmaceuticals for companion animals. The company will develop its lead product, SMN-023, to treat atopic dermatitis in dogs, based on Spherium's intellectual property. Under the terms of the agreement, Simini gains exclusive worldwide rights to develop and commercialise all veterinary products of the technology supporting SP14019, in exchange for development and commercial milestones and royalties.

Spherium is very happy with the commitment of the Simini team to the project: impressive, bound to succeed.

 

12 DE ABRIL DEL 2018

Cyclatop© for atopic dermatitis heating up!

In February, Spherium Biomed completed enrolment in the Cyclatop© (SP14019) trial. This phase IIa clinical study in paediatric and adult patients with mild to moderate atopic dermatitis is designed as a proof-of-concept, multi-centre, randomised, double-blind, vehicle-controlled study with intra-individual comparison of treatments (left-right design so that every patient receives both placebo and treatment).

Three age cohorts of patients from nine different hospitals in Spain, including leading paediatric centres, have been successfully included in the study according to pre-defined criteria: adults, juveniles and children.

The main objectives are to assess the efficacy of the Cyclatop© topical solution (5% cyclosporine) compared to a placebo topical solution in treating patients with mild to moderate atopic dermatitis and to evaluate the safety and the tolerability (5% CsA) in patients with mild to moderate AD.

Spherium is developing Cyclatop© under an exclusive license from Bionanoplus, a drug-delivery company located in Navarre (Spain), and based on the company’s intellectual property. “We expect to have top-line results during the second quarter of 2018,” says Benjamín Santos, senior project manager at Spherium.

  • 29 DE ENERO DEL 2018

    Are we really Agile enough?

    In the early 2000, developers proposed Agile project management methodology as an alternative to the traditional waterfall-like project panagement in software projects. Agile was the answer to a common issue: how to deliver FASTER the right...

  • 24 DE ENERO DEL 2018

    Spherium is approaching key clinical milestones

    Two projects in Spherium Biomed's portfolio are approaching the key milestone usually known as “topline clinical results”: Mucomel® (SP13004) and Comboprofen® (SP12006).

    Mucomel trial, a double-blind, placebo controlled safety and efficacy...

  • 16 DE ENERO DEL 2018

    Discover Spherium's pipeline at BIO-Europe Spring 2018!

    Spherium Biomed will be at the BIO-Europe Spring Conference in Amsterdam from the 12th to the 14th of March. This benchmark event in biotech innovation in Europe will bring together more than 2,500 key opinion leaders and other attendees.

     Spherium’s...

29 DE ENERO DEL 2018

Are we really Agile enough?

In the early 2000, developers proposed Agile project management methodology as an alternative to the traditional waterfall-like project panagement in software projects. Agile was the answer to a common issue: how to deliver FASTER the right VALUE for the client.

 Imagine the situation: under traditional approaches, long project timelines and constant changing client needs fed each other in a very inefficient cycle. A client defined the initial requirements for a requested product; once the product was finally delivered, it did not met current (updated) client needs, so an even longer times are required to deliver a product matching the newly defined requirements. Product that once released to the client did not met again his current (once again re-updated) needs, and so on and so forth.

 Uncertainty (in client final requirements) was the driving force feeding this tornado. Frustration, both at the project manager and the client side, was the only surely result. Agile methodology gathered at that point the best practices in lightweight methods of project management summarizing its goal in a very provocative manifesto (see below) and 12 principles worth checking (go ahead, google it!).

 “We come to value:

 - Individuals and interactions over processes and tools

- Working product over comprehensive documentation

- Customer collaboration over contract negotiation

- Responding to change over following a plan

That is, while there is value in the items on the right, we value the items on the left more.”

Customer involvement, incremental delivery of value and motivated teams were key elements of this approach that changed forever the paradigm of project management, becoming the industry standard in IT projects.

Since uncertainty (mainly technical uncertainty) is the name of the game in R&D, it seems obvious that Agile management will also be as helpful in managing Biotech projects in a more efficient way, as it has been proven in IT. In fact, we should not be talking in future tense, Agile probably is already here (maybe not fully deployed) although perhaps we haven't realized it yet.

This is the case at Spherium Biomed. Our innovative business model and our internal flexibility has helped us over the last years to adopt some tools from Agile methodology. Frequent feedback from the market to validate client needs and project TPP and milestones, continuous and incremental delivery of value of the projects though their lifetime, face-to-face communication, dynamic and self-organized teams... are some of the elements that we have implemented. These features are key in helping us to react to any change on the project or portfolio and to efficiently add value to the projects in every step along the way.

Of course, considering some of the intrinsic restrictions of our industry (long times of clinical activities, large budget and resources commitment, strict regulatory requirements and timelines...) traditional approaches will probably remain as the foundation of biotech R&D project management for the years to come. Still, we have no doubt the Agile management will find his place among us.

In the light of the main objective that we all share, to serve patients’ needs, and in the complex circumstances that pharma industry faces: we cannot force biology to work with our rules and we cannot reduce investment to the limit that compromises quality in the development of products, there is only one dimension in which we can do really better. We can be faster to deliver results for the benefit of patients. We will see in the future new hybrid approaches combining the best practices from both worlds. In this sense, the real question for those developing new drugs will not be if we work or not under Agile methodologies, it simply will be if we really are Agile enough.

Pedro Grima, Senior Project Manager at Spherium Biomed 

24 DE ENERO DEL 2018

Spherium is approaching key clinical milestones

Two projects in Spherium Biomed's portfolio are approaching the key milestone usually known as “topline clinical results”: Mucomel® (SP13004) and Comboprofen® (SP12006).

Mucomel trial, a double-blind, placebo controlled safety and efficacy study for prevention and treatment of mucositis in head and neck cancer patients, was completed in December. 84 patients from 11 centres in Spain were enrolled and treated, so we expect to close the database soon and have the results by March.

 In the same situation is the proprietary fixed dose combination Comboprofen®. Spherium successfully enrolled 70 volunteers and evaluated Comboprofen® and its individual components versus placebo in a clinical efficacy trial measuring the evolution of delayed onset muscular soreness (DOMS) after intensive exercise. The company expects to have results next March. 

Meanwhile, Cyclatop® trial on atopic dermatitis, evaluating the efficacy of the SP14019 topical cyclosporine spray on paediatric and adult patients, is recruiting at good pace. The results of the trial to be available by June this year. 

Also, we will start phase I on another clinical programme this year with SP15016, a drug candidate to prevent acute kidney injury in angioplasty patients receiving a high dose of iodinated contrast agent.

Exciting times for Spherium. The four key clinical milestones this year will turn our hopes into evaluable results. Expectations will become objective data. The binomial nature of the biotech industry at its best, just three months ahead. Keep you posted. 

16 DE ENERO DEL 2018

Discover Spherium's pipeline at BIO-Europe Spring 2018!

Spherium Biomed will be at the BIO-Europe Spring Conference in Amsterdam from the 12th to the 14th of March. This benchmark event in biotech innovation in Europe will bring together more than 2,500 key opinion leaders and other attendees.

 Spherium’s main goal is to partner out their current pipeline, “while keeping up contact with universities and research centres from around Europe to learn about their new pipeline opportunities,” explains Maribel Bergés, Managing Partner and CBDO at Spherium.

 First-in-class preclinical projects

 The Spherium pipeline, the main driver of the company’s current value, includes innovative drugs in the clinical stage, such as SP13004, with a unique disease-modifying mechanism of action to prevent and treat mucositis caused by cancer therapy; SP14019 to treat atopic dermatitis and psoriasis with a proprietary topical spray formulation of cyclosporine; and SP12006 for mild to moderate muscular pain associated with sport or temporomandibular joint disorder.

 These three projects will deliver efficacy results in the first quarter of 2018. This huge short-term milestone has the potential to transform the company and turn it into a very interesting investment opportunity.

 On top of these projects, the company’s portfolio includes four more first-in-class preclinical projects ready to start regulatory development and an IND-ready project (SP15016) for prevention of iatrogenic acute kidney injury.

 Would you like to schedule a meeting with us?

 Related news: Spherium's key patent achievements in 2017

  • 8 DE ENERO DEL 2018

    Spherium's veterinary affiliate Aquilon raises €1.1M funding round

    Aquilón, Spherium Biomed's veterinarian spin-out located in the University of León (Spain), has closed out a series B round of 1.1 million euros with investors from Alentia, venture group Clave Mayor and Spherium.

    The company develops...

  • 21 DE SEPTIEMBRE DEL 2017

    Spherium completes patient enrollment for first-in-class mucositis drug in cancer

    Spherium Biomed announces that recruitment for its Mucomel’s phase Ib/IIa clinical trial has been completed. Mucomel (SP13004) is a high-load muccoadhesive oral gel of melatonin, intended for the prevention and treatment of oral mucositis...

  • 20 DE SEPTIEMBRE DEL 2017

    Spherium's key patent milestones in 2017

    Strategic Intellectual Property (IP) management is a key element for any company focused in drug development. Spherium Biomed is not the exception. The company sources most of their projects from academic institutions which are usually...

8 DE ENERO DEL 2018

Spherium's veterinary affiliate Aquilon raises €1.1M funding round

Aquilón, Spherium Biomed's veterinarian spin-out located in the University of León (Spain), has closed out a series B round of 1.1 million euros with investors from Alentia, venture group Clave Mayor and Spherium.

The company develops innovative vaccines, probiotics and diagnostics to improve the productivity in the animal livestock industry aiming to diminish or replace the use of antibiotics. Flagship developments are a first in class vaccine against swine dysentery, ready to start field trials, and a tagged vaccine to bovine viral diarrhea virus (BVDV).

 Aquilón expects to partner its veterinary vaccines during 2018 and 2019 and launch with partners worldwide its probiotics for piglet disbiosis by 2019. Next key milestone will be completing the development of the brucellosis diagnostic and showing in vivo proof of concept for the tagged vaccine against BVDV.

 Related news: Aquilón opens a funding round

21 DE SEPTIEMBRE DEL 2017

Spherium completes patient enrollment for first-in-class mucositis drug in cancer

Spherium Biomed announces that recruitment for its Mucomel’s phase Ib/IIa clinical trial has been completed. Mucomel (SP13004) is a high-load muccoadhesive oral gel of melatonin, intended for the prevention and treatment of oral mucositis associated with chemotherapy and radiotherapy in cancer.

The phase Ib/IIa clinical trial focuses on the evaluation of safety and efficacy of Mucomel in head and neck cancer patients undergoing both radio and chemo/biotherapy. A total of 84 patients have been enrolled in 11 different hospitals across Spain. Last-patient last-visit is planned for the end of the year and topline results will be available during the first quarter of 2018.

'It is an important milestone for Spherium together with the other two phase II clinical trials, and it shows that our business model delivers results in a consistent pace' says Ramon Bosser, COO of the company. In particular, Mucomel's achievements 'brings us closer to our ultimate goal: offer to cancer patients the first-ever preventive treatment of severe oral mucositis.'

Certainly, this achievement is the result of the common effort of a great team of clinicians and experts from ICO L'Hospitalet, ICO Girona, ICO Badalona, Hospital de Sant Pau (Barcelona), Vall d'Hebron University Hospital (Barcelona), La Paz University Hospital (Madrid), Hospital San Carlos (Madrid), Miguel Servet University Hospital (Zaragoza), Hospital Virgen de la Victoria (Málaga), USC University Hospital Complex (Santiago de Compostela) and Marqués de Valdecilla University Hospital (Santander).

“None of this work would have been possible without their teamwork, commitment and enthusiasm” remarks Bosser.

In the picture from left to right, Dr. Alicia Lozano, principal investigator of Mucomel's trial at the ICO L’Hospitalet, Dr. Germaine Escames, originator of Mucomel's technology at the University of Granada, and Dr. Cristina Tarragó and Dr. Pedro Grima, Senior Project Managers at Spherium.

20 DE SEPTIEMBRE DEL 2017

Spherium's key patent milestones in 2017

Strategic Intellectual Property (IP) management is a key element for any company focused in drug development. Spherium Biomed is not the exception. The company sources most of their projects from academic institutions which are usually of public nature.

“We take full responsibility not only for the regular, reactive maintenance and defense of the IP we license from universities, but also for the prospective, proactive generation of data to support the evaluation process. And sometimes we generate experimental results that allow us to deliver new IP, always in coordination with the original inventors” explains Luis Ruiz-Ávila, CEO of Spherium Biomed.

So, it’s time to look at what happened during the first half of 2017 in the IP front. Spherium leaves up to the readers to decide if the results are consistent with what is described above:

Mucomel (SP13004): The patent that protects our mucositis product has been granted in China, Japan, Mexico, Russia, Australia, US and the EU.

Cyclatop (SP14019): In January, Spherium filed a composition of matter Patent Cooperation Treaty (PCT) application for this topical Cyclosporine solution for atopic dermatitis and psoriasis. The patent application was published last July. The product is also covered by an umbrella patent already granted in the US, Japan and Australia.

Comboprofen (SP12006): The PCT application of this mild muscular pain product received a very positive written opinion from the European Patent Office (EPO). Spherium entered national and regional phases in the more relevant markets last March.

SP15016: A key patent covering this product for prevention of drug-induced acute kidney injury was granted in the US.

SP14040: Spherium's cognition deficit product has seen the 2014 application deemed grantable in some countries. The company expects this application to be accepted “as is” in several countries over the next year, confirming the high scientific level of the research and the quality standards of the tech-transfer team at the Jagiellonian University in Poland.

SP12008: Part of the broad patent application covering this preclinical biological candidate for autoimmune diseases has been granted in Europe and Australia and validated in the most relevant European countries. Spherium filed a new patent application in July and plans to file for new patents in the next months.

SP15028: The international patent application of Spherium's product for the acute, local and fast regenerative treatment of muscle injury has entered national and regional phases in the most relevant markets.

All these achievements couldn’t have been possible without great foundations. Spherium works closely with such excellent and diverse research and tech-transfer teams from all over the world. Such commitment translates in an ever-growing investment from our side as the portfolio IP reaches maturity.

  • 18 DE SEPTIEMBRE DEL 2017

    Spherium to present growing prospects to investors in Basel

    Spherium Biomed will be at the 17th Annual Biotech in Europe Forum on September 26th and 27th in Basel (Switzerland). The event will bring together more than 650 delegates from biotech and life sciences industry and investment funds looking...

  • 4 DE SEPTIEMBRE DEL 2017

    Don’t expect a street with your name

    Most of us go through life quite anonymously, pretty normal considering that there are 7.5 billion people around and at least ten times that figure already dead. In this context, my 1403 Linkedin contacts don’t qualify me as a famous person...

  • 12 DE JUNIO DEL 2017

    Aquilón, Spherium's veterinarian spin-out, opens a funding round

    Aquilón, Spherium Biomed's veterinarian spin-out located in León (Spain), has opened a series A funding round to expand and progress its pipeline and consolidates the diagnostics division.

    Aquilón is developing innovative products for...

18 DE SEPTIEMBRE DEL 2017

Spherium to present growing prospects to investors in Basel

Spherium Biomed will be at the 17th Annual Biotech in Europe Forum on September 26th and 27th in Basel (Switzerland). The event will bring together more than 650 delegates from biotech and life sciences industry and investment funds looking for potential matches to finance or partner.

Spherium’s presentation is scheduled for 10:35 am on September 27th. “We will share with potential investors our strategic plan to manage the growth of the company during the next four years” explains Maribel Bergés, CFO of the company. The aim is to raise awareness in the international investor community in preparation for a financing round in 2018.

Besides the public presentation, during the two days of the conference there will be plenty of opportunities to meet interested parties one-to-one.

First-in-class preclinical projects

The Spherium pipeline, the main driver of the company’s current value, includes innovative drugs in clinical stage like SP13004, with a unique disease-modifying mechanism of action to prevent and treat mucositis caused by cancer therapy; SP14019, to treat atopic dermatitis and psoriasis with a proprietary topical spray formulation of Cyclosporine, and SP12006, for mild to moderate muscular pain associated with sport or temporomandibular joint disorder.

These three projects will deliver efficacy results during the first quarter of 2018, a huge short term milestone with potential to transform the company and turning it in a very interesting investing opportunity. On top of these projects the company’s portfolio includes four first-in-class preclinical projects ready to start regulatory development and an IND-ready project (SP15016) for prevention of iatrogenic acute kidney injury.

Related news: Spherium's key patent achievements in 2017

 

 

4 DE SEPTIEMBRE DEL 2017

Don’t expect a street with your name

Most of us go through life quite anonymously, pretty normal considering that there are 7.5 billion people around and at least ten times that figure already dead. In this context, my 1403 Linkedin contacts don’t qualify me as a famous person, nor the fact that I appeared in local TV News in New Jersey when a snow storm left fabulous slopes in a park in Nutley and I was having a great time sliding down with my 4 year old son. We need to accept that, in general, the chance of convincing a public body to name a street after us is fairly small.

Still, there is some hope for those of us in the innovative drug development business, an activity that, time to time, causes an enormous impact on society. Unfortunately we are sitting on just around 500 truly innovative drugs, and the game changers we come up every year are in the very low single digit range. So our profession gives us some above-the-average chance to access street immortality, but still in the “win the eurojackpot” probability ball park. Add to this that nowadays developing a drug is a huge collaborative effort where it is difficult to give the full credit to a single person, and that the economics of the drug development business makes it not precisely a favorite of the media or the public bodies. A sensible conclusion to all this reasoning is that, if you want a street, just don’t get into drug development.

This said… who cares? I can only say that the few extraordinary individuals I met that had the privilege to discover, develop or launch a meaningful drug belong to a quite happy and professionally-satisfied bunch. Not to mention the really exceptional cases where the same individual had participated in all the process, from the discovery to launching, and even more exceptional when you are talking of persons that are at the same time inventors and developers, witnessing hands-on the growing of their own creatures from the very first experiment to the filing of the NDA, or at least to the administration of their drugs to patients for the first time.

I remember vividly the face expression of a young researcher we had hired as project manager, when she received from the regulatory agency the formal communication approving the phase Ib clinical trial of a drug that, 7 years before, she had discovered, characterized and patented during her PhD in the University from where we licensed the rights. I’ve never seen a happier and more satisfied person in my life.

We are privileged because our business model facilitates these things to happen. Proud to see that in the last four years we were able to transform several PhD thesis in clinically relevant products, with a close complicity from the academic inventors who, without any doubt, have enjoyed more than one moment of supreme professional and personal satisfaction as their discoveries advanced in the value chain. I wonder if we could write a secret mission for Spherium Biomed, something along the line “to increase the chance somebody gets a street because of a relevant drug”. Keep you posted.

Luis Ruiz-Ávila, CEO of Spherium Biomed

12 DE JUNIO DEL 2017

Aquilón, Spherium's veterinarian spin-out, opens a funding round

Aquilón, Spherium Biomed's veterinarian spin-out located in León (Spain), has opened a series A funding round to expand and progress its pipeline and consolidates the diagnostics division.

Aquilón is developing innovative products for increasing the productivity in livestock animals. The three most important keywords in its value proposition are alternative to antibiotics. Antibiotic use in intensive breeding of livestock is a serious concern due to its potential impact in the extension of antibiotic resistance to human bacteria. The veterinarian industry is acting consequently, with a clear shift in R&D priorities, focused now in improved diagnostics, better vaccines and probiotics.

Spherium Biomed spun-out Aquilón in 2012, in collaboration with the University of León and the financial support of the venture group Clave Mayor. Aquilón mirrors Spherium’s business model in many ways: lean structure, focus on project management, sourcing from academia… The company is now reaching maturity. It generates revenues on the sales of diagnostics services and swine dysentery auto-vaccines in Spain, and has an active development portfolio: two products approaching registration (a probiotic for the improvement of piglet dysbiosys and an improved diagnostic for swine brucellosis), a first-in-class vaccine to Swine Dysentery undergoing experimental efficacy, and two early stage potentially ground-breaking projects for important bovine and poultry diseases. Also it is expected that Aquilón will sign important deals in 2017 for the probiotic and dysentery vaccine projects.

  • 12 DE JUNIO DEL 2017

    Spherium prepares a clinical trial of Comboprofen® to treat DOMS

    Spherium Biomed has new milestones of Comboprofen® project (SP12006), a patented fixed dose combination for the treatment of mild to moderate muscle pain. The combination is primarily targeting pain related to micro lesions in the muscle...

  • 6 DE MARZO DEL 2017

    An Astronaut’s guide…. to biotech Project Management

    It was about three years ago when I was coming back from BioTrinity in London. It had been a good event and we had had a lot of one-to-one meetings where we had tried to explain to a number of universities and hospitals why it could be...

  • 14 DE FEBRERO DEL 2017

    Advances in Spherium's clinical portfolio

    Spherium Biomed's portfolio is steadily advancing to reach the preclinical and clinical value inflection points. From the clinical portfolio, all three ongoing trials reached recently important milestones as a result of the commitment and...

12 DE JUNIO DEL 2017

Spherium prepares a clinical trial of Comboprofen® to treat DOMS

Spherium Biomed has new milestones of Comboprofen® project (SP12006), a patented fixed dose combination for the treatment of mild to moderate muscle pain. The combination is primarily targeting pain related to micro lesions in the muscle fibers caused by exercise that appears after 24 or 48 hours, technically referred to as Delayed Onset Muscle Soreness or DOMS.

Spherium has successfully developed a clinical protocol for muscular pain induction related to sports practice in close collaboration with the medical and biomechanical specialists of the High Performance Sports Centre (CAR), a reference installation for top-level athletes from all over Europe, located in the city of Sant Cugat del Vallès (Barcelona, Spain). 'This excellent work have allowed us to design a clinical trial JAN12006-09 to evaluate the efficacy and safety of the product for the treatment of DOMS' explains Benjamín Santos, Senior Project Manager of Spherium. The study, approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) last May, will be carried out in the facilities of the Centre for Drug Research (CIM) of the of the Hospital de la Santa Creu i Sant Pau in Barcelona.

Another relevant milestone has been the completion of Spherium's first-ever phase II study, JAN12006-01, a 96-patient multicentric trial to evaluate the efficacy and safety of Comboprofen® in the treatment of the acute pain of the temporomandibular joint with muscular component, a clear unmet medical need in odontology. 'We expect to have all the results and conclusions during the third quarter of 2017' says Santos.

Without a doubt, It is an exciting time for the company specialised in international licensing and tech transfer.

6 DE MARZO DEL 2017

An Astronaut’s guide…. to biotech Project Management

It was about three years ago when I was coming back from BioTrinity in London. It had been a good event and we had had a lot of one-to-one meetings where we had tried to explain to a number of universities and hospitals why it could be a good idea for them to license out their projects to Spherium Biomed and how we could help them to test their inventions and eventually increase their value.

Having taken the Gatwick express too early, I was now just wandering around the airport and waiting for my flight. I realized I still had 20 pounds in my pocket, and I was trying to invest them in something worth to before my return to the Euro space, when I entered the newspapers shop and saw this paperback edition with an astronaut picture on the front page. It came to me like an old dream from some years ago, when I was young, I had this idea of becoming an astronaut myself, an idea that had to be abandoned for a more down-to-earth professional plan when I learned about the extremely demanding vision requirements. So I bought the book. An astronaut’s guide to life on earth by Canadian astronaut Chris Hadfield and I started to discover the secrets of this profession that most of us will never get to really know, and learn about the lights and shadows that are so surprisingly close to our own.

As commander Hadfield describes his profession, it takes years to become an astronaut, since they need to keep always learning about the prospects of out of earth missions and getting their minds to think like astronauts: “No matter how competent or how seasoned, every astronaut is essentially a perpetual student forever cramming for the next test”. It takes hours of simulations, debriefing, courses, reading, and homework for an astronaut to be ready to take a mission, and yet we only know about them when a new record is achieved or something epic or sometimes even disastrous happened in their last mission. Another important advice from Hadfield is to prepare previously to each mission, even a single recognition flight, to check every potential problem that may come up and be ready for the unexpected events, as he puts it, you need to “sweat the small stuff” so you know ahead of a situation all the potential trouble you may find.

It turns out that it is very similar when you come to biotech Project Management. We will never have the thrill of actually leaving the ground to come higher than the 50 miles that it takes to be an astronaut, but a Project Manager is also a lifetime student that invests an incredible amount of time learning about the very specifics of a new mechanism of action, the properties or a complex biological system, or the clinical needs in a particular indication. Before starting a new experiment, may it be a murine model or a clinical trial, there are a number of small decisions to be taken in order to learn the most from the experience: how to administer the product, how many doses, how often, which are the readouts that are going to be collected and reported, and then we need to debrief to understand what happened, what went right and what went wrong, and start to plan for our next experiment again.

So what makes us good as Project Managers and, in a word, why should anyone want to partner with us? It is not so much about how good or exceptional are our successes, but it is about how long our hours have been in this field and how deep and extended is our experience. It is about how many experiments we have seen, how many right or wrong decisions we have made, how many projects we started and how many failed and how our team has learned from all that to bring it to any new development we start.

Since we incorporated Spherium Biomed, we have reviewed in depth more than 500 projects, we have started almost 70 new preclinical developments after closing as many licenses, and we are now conducting three phase II clinical trials. This is the real value that we can bring to an academic research organization: the experience and time it has taken to our team to be developing projects continuously for the last eight years. Or to say it in the words of Michael Jordan: “I've missed more than 9000 shots in my career. I've lost almost 300 games. 26 times, I've been trusted to take the game winning shot and missed. I've failed over and over and over again in my life. And that is why I succeed”.

In the next months we will learn the results of our first three clinical trials, we may succeed or we may fail, but no matter what we will debrief and learn to bring the best of our experience to our technological partners (worldwide universities and hospitals) and to the patients that deserve the best of our efforts to develop biomedical innovations for the improvement of their health.

Now the countdown is ready for our first results, in a way, our first lift-off. 5…4...3…2…1…

Maribel Berges, Managing Partner and CBDO of Spherium Biomed

14 DE FEBRERO DEL 2017

Advances in Spherium's clinical portfolio

Spherium Biomed's portfolio is steadily advancing to reach the preclinical and clinical value inflection points. From the clinical portfolio, all three ongoing trials reached recently important milestones as a result of the commitment and hard work of the internal and external collaborators involved in these projects.

Most relevant goal was reached by SP12006, the program in Temporo-Mandibular Joint Disease (TMJD). In this project, the phase II clinical trial successfully completed the recruitment of 96 patients in 4 different centers: the Universitary Dental Clinic (UIC), the Hospital Odontológico of the University of Barcelona, the Universitary Hospital Rey Juan Carlos I in Madrid and the University Hospital de la Fe in Valencia. This exploratory trial is a randomized, double blind, placebo controlled study designed to evaluate safety and efficacy of a triple combination (ibuprofen, magnesium and vitamin C) for the treatment of acute pain in TMDJ. 

Another relevant milestone was reached by SP14019, the program in Atopic Dermatitis (AD). In this case, the phase II clinical trial successfully completed the recruitment of the adult cohorts, which allows Spherium Biomed to start the recruitment of children under 18 years. AD is a major unmet need in the children, so testing in this population is a critical objective of the project.

Finally, the program in Oral Mucositis (OM) SP13004 also has shown important advances: phase Ib-II clinical trial (reached the recruitment of 2/3 of the target patient population, and is actively recruiting at a steady pace.

'In summary we had a very busy clinical year, but we expect 2017 to be even busier.
Next milestone ahead: top line results of our clinical TMJD program, expected in the coming weeks' explain Dr. Benjamín Santos and Dr. Wilmar Castillo Ávila, Project Managers at Spherium Biomed.

  • 12 DE FEBRERO DEL 2017

    Mucomel® at the 6th International Conference on Innovative Approaches in Head & Neck Oncology

    Spherium Biomed will attend to the 6th International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO) from 16th to 18th March 2017 in Barcelona to share with the medical experts in this field both the preclinical background...

  • 9 DE DICIEMBRE DEL 2016

    Let’s keep it simple

    Most of us make a living on biotech thanks to the April 1953 Nature paper, A Structure for Deoxyribose Nucleic Acid” recognized as the landmark starter of modern biology. The paper is a one pager: Watson and Crick used just 985 words distributed...

  • 27 DE SEPTIEMBRE DEL 2016

    Cyclatop estudio para la dermatitis atópica se inicia el reclutamiento de pacientes

    Spherium Biomed ha abierto el primero de ocho hospitales en España, que participan en el estudio Cyclatop, para evaluar la seguridad y eficacia de un aerosol cutáneo propio de la ciclosporina A (codificado SP14019-F1) para el tratamiento...

12 DE FEBRERO DEL 2017

Mucomel® at the 6th International Conference on Innovative Approaches in Head & Neck Oncology

Spherium Biomed will attend to the 6th International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO) from 16th to 18th March 2017 in Barcelona to share with the medical experts in this field both the preclinical background and the design of the ongoing trial Mucomel®.

In the phase IB-II clinical trial, Spherium Biomed investigates the safety and efficacy of a proprietary oral gel for the prevention and treatment of severe oral mucositis in 84 patients with head and neck cancer undergoing radio/chemo therapy. At present, the trial is actively recruiting patients in seven leading hospitals in Spain (ICO L’Hospitalet, Vall d’Hebron University Hospital and Hospital Sant Pau in Barcelona, ICO Girona, ICO Badalona, Miguel Servet University Hospital in Zaragoza and La Paz University Hospital in Madrid). Recruitment pace forecasts that last patient will be included by June 2017.

Severe oral mucositis is a major adverse event of the oncologic treatment with a large incidence: 95% of head and neck cancer patients, 78% of haematological cancer patients, 40% of patients with solid tumors, among others. It is recognized by experts as one of the major unmet medical needs in cancer supportive care, since at present only partial symptomatic treatments are available (anesthesic washes, hygiene procedures and anti-inflammatories) and consequences of the disease can led to breaks in oncologic treatment, parenteral feeding and oral chronic toxicities. Mucomel® represents a unique opportunity to improve the quality of life for these patients.

During the 6th ICHNO, five posters related to melatonin, mucositis and cancer will be presented. The design of Spherium Biomed's clinical study will be summarized in the poster entitled Melatonin oral gel for the prevention of oral mucositis H&N cancer undergoing chemo/bio radiation, presented by the principal investigator Dra. Alicia Lozano. The preclinical in vivo results of the use of melatonin in prevention of oral mucositis will be summarized in two posters, Effects of melatonin oral gel to prevent radiation-induced mucositis model in rat and A melatonin gel protects the mitochondria from radiation damage preventing radiotherapy-induced mucositis, that will be presented by the originator of the Mucomel® technology, Dra. Germaine Escames. She will also present two posters summarizing her ongoing research work on melatonin at the University of Granada: Oncostatic effect of Melatonin in H&N cancer: role of mitochondrial function and Melatonin enhances the toxicity of Radio- and Chemotherapy in H&N cancer cells.

Meet Spherium Biomed at the 6th ICHNO! Please contact in advance our representatives Dr. Cristina Tarragó and Dr. Pedro Grima in order to arrange a meeting during the conference.

9 DE DICIEMBRE DEL 2016

Let’s keep it simple

Most of us make a living on biotech thanks to the April 1953 Nature paper, A Structure for Deoxyribose Nucleic Acid” recognized as the landmark starter of modern biology. The paper is a one pager: Watson and Crick used just 985 words distributed in less than 6.000 characters and one drawing to describe the double helix of DNA and to suggest how its information could be copied and transmitted from one generation to the following.

“Distrust the idea that does not fit in a sentence”, says Jorge Wagensberg in his marvelous short aphorism book If Nature is the answer, what was the question? Simplicity is a key to understanding problems and to make others understanding the problems, also a key to propose solutions to problems. Simplicity helps in any kind of communication. However, sensible simplification is probably the most challenging effort for anyone with communication responsibilities, from the community manager in the Linkedin page to the CFO talking to investors; from the bench scientist telling the CEO how important the new program is for the company, to the University Professor explaining the tech transfer guys her last discovery (which by the way could be the next Watson & Crick thing…).

Ever heard of the elevator pitch concept?

Counter-example: I remember one honest and hard-working man going all over Spain explaining a full range of public financing options for science projects. He had 30 slides and his concept of adaptability was this: if he had 30 minutes, his presentation was OK, normal pace. If he had 45 minutes, then he explained his 30 slides at a slower, mindfulness-style rhythm. If he had only 10 minutes, then he was really fast, still showing the 30 slides.

We started Spherium Biomed in 2009. Our name was Janus at the time, after the bi-faced Roman divinity taking care of the transitions (January…), looking at the same time to the past and to the future. We thought of Janus because we wanted to look at the academic research and the unmet needs in the biomedical market and bridge the gap (our first catchy motto). Simultaneously we defined our mission as to turn biomedical knowledge into social and economic value. We spent infinite hours trying to find a sentence to define our company, a simple, easy-to-remember and true statement fitting in a short sentence that even my mum could understand.

During our first four years we tried several adaptations of known concepts: hands-on biomedical incubator; accelerator, a company specialized in maturing projects originated in academia; or cost-efficient de-risk incubator of biomedical technologies. All that time we spoke a lot with different local journalists who were interested in the evolution of the company. A symptom of us not communicating well was that one of them systematically defined us as a consulting firm giving strategic advice to research institutions, no matter how nice our pipeline started to look or how many licensing-in deals we had closed with academia.

Seven years have gone-by already, and we are still looking for that sexy and informative short sentence that defines as better. As of today we are a clinical stage biopharmaceutical company that sources its pipeline from academic research. Perhaps it is a good definition. For sure we will have another one in a couple of years.

Yes, I’ve checked already. The post has 566 words including this sentence. 3414 characters including spaces. No drawings.

It may work.

Dr. Luis Ruiz-Ávila, CEO of Spherium Biomed

27 DE SEPTIEMBRE DEL 2016

Cyclatop estudio para la dermatitis atópica se inicia el reclutamiento de pacientes

Spherium Biomed ha abierto el primero de ocho hospitales en España, que participan en el estudio Cyclatop, para evaluar la seguridad y eficacia de un aerosol cutáneo propio de la ciclosporina A (codificado SP14019-F1) para el tratamiento de leve dermatitis atópica (AD) de leve a moderada, cubriendo todos los grupos de edad, incluida población pediátrica. En él se incluirán 36 pacientes (con un diseño cegado de izquierda-derecha, de tal manera que cada paciente es su propio control) con edades comprendidas de 2 a 75 años en tres cohortes (pediátricos, juveniles y adultos).

Systemic Cyclosporine A is an efficacious and well established treatment for moderate to severe atopic dermatitis. Its use is limited to short term because of the risk of adverse events, in particular nephrotoxicity. The topical formulation is expected to have a much better safety profile since it reduces dramatically the systemic exposure. “In our view it represents a unique opportunity to extend the well-established benefits of cyclosporine in the indication, both in time (allowing for longer treatment periods) and in patient base (broadening the scope of treatment to milder cases and pediatric populations)” explains Dr. Benjamín Santos, Senior Project Leader of Spherium Biomed.

20% of Spanish children suffer from atopic dermatitis

Atopic dermatitis , also called atopic eczema, is a chronic and relapsing inflammatory skin disease affecting up to 20% of children and up to 3% of adults depending on the country. Its prevalence is still on the rise. The disease is characterized by itchy skin lesions and rashes. It is primarily managed in primary healthcare settings and often is considered a minor condition, but it has a significant impact in quality of life and in costs for the health-care systems and families. When its first manifestations appear early in life it often precedes other allergic diseases such as asthma or allergic rhinitis.

The global market is in the 4 billion dollar range worldwide, with an estimated target population of 54 million people for the next decade. The long lasting nature of AD and the multiple etiologies underlying the disease are the basis for the existence of many therapeutic options and, simultaneously, of an intense research activity focused in niche unmet needs in severe, refractory cases, and in expanding the current armamentarium, especially topical alternatives for infants.

Presentation at the 25th EADV Congress

Spherium Biomed high-load formulation of Cyclosporine A is compatible with cutaneous spray administration. “We have already shown that the formulation delivers appropriate amounts of Cyclosporine to the target layers in the skin, with a parallel, dose dependent efficacy in preclinical models of atopic dermatitis,” says Dr Santos. The key aspect of SP14019 development has been solving the pharmaceutical challenge of obtaining a high-load, skin penetrating, scalable, stable and regulatory compliant formulation of CsA, a technical milestone that we couldn’t have achieved without the close collaboration with Bionanoplus, a Navarra University spin-off from which we licensed the technology in exclusive for this project. Dr. Benjamin Santos will present the project at an oral poster (Stable, high-load topical formulation of Ciclosporin for the treatment of Psoriasis and Atopic Dermatitis) at the 25th EADV Congress in Vienna  on 1st October .

This is the third project of Spherium Biomed's portfolio that reaches clinical efficacy stage over the last year. Exciting times ahead, since the three of them are expected to deliver top line results before the end of 2017. Keep you posted! 

 
  • 27 DE SEPTIEMBRE DEL 2016

    El desarrollo de nuevos fármacos: “from push to pull”

    Artículo de opinión escrito por Luis Ruiz-Ávila, PhD CEO de Spherium:

    Biomedicine is the most unpredictable of all sciences. Take thousand engineers and close them down in a quiet Pacific Island. Give them ten billion dollars and specific...

  • 13 DE ENERO DEL 2016

    SPHERIUM INICIA UN ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA DE UN PRODUCTO PARA TRATAR EL DOLOR EN LA ARTICULACIÓN DE LA MANDÍBULA

    Spherium ha iniciado la inclusión de pacientes en un ensayo clínico para evaluar la eficacia de SP12006 para el tratamiento del dolor agudo asociado a los trastornos temporo-mandibulares. El ensayo incluirá 96 pacientes provenientes de...

  • 14 DE OCTUBRE DEL 2014

    Aquilon gana el premio Cinco Días

    Aquilón Cyl SL ha sido elegida como empresa más innovadora por los premios Cinco Días a la innovación empresarial en su edición de 2014. El premio reconoce el modelo de negocio de la compañía, basado en transformación de conocimiento académico...

27 DE SEPTIEMBRE DEL 2016

El desarrollo de nuevos fármacos: “from push to pull”

Artículo de opinión escrito por Luis Ruiz-Ávila, PhD CEO de Spherium:

Biomedicine is the most unpredictable of all sciences. Take thousand engineers and close them down in a quiet Pacific Island. Give them ten billion dollars and specific instructions to deliver a new plane in 10 years. They most probably will deliver the new plane according to specifications. Take thousand biomedical scientists and do the same asking them to deliver an HIV vaccine, and they most probably won’t get it.

Applied biomedical research, particularly new drug development, is a pay per view business and the quintessence of the scientific method: no matter how good is your science, the only way to know if your hypothesis is right is to test it experimentally in the right model. And, in biomedicine, key experiments are outrageously expensive (the right model is a human and the experiments are called clinical trials) and surprises (unexpected results) are more the norm than the exception. Anybody in applied biomedical research has to learn to cope with technical failure. Actually, the real challenge of an R&D executive in the biopharma industry is to be able to minimize the cost of failures while performing sufficient number of attempts to get at least one drug to the patients once in a while, without being fired along the way because of incompetence or budgetary restrictions. 

 

There are two basic approaches to deliver a new drug: pull and push. The pull approach follows a very institutionalized path in the biopharma industry: define a medical unmet need, find a new therapeutic target, discover a molecule that acts on the target, show it works in preclinical models of the predefined unmet need, make the molecule industrial and regulatory compliant, define the clinical and market access strategy, take a deep breath and start formal development. It is a problem-driven approach. The key element is to find the right technology to solve a predefined problem. The driver of the process is the dedicated industry, that expends enormous amount of resources in understanding and predicting unmet medical needs, payer trends and, sometimes, even defining new diseases or disease sub-classifications. 

The push, by contrast, is technology-driven. One team of scientists makes a seminal discovery, then the key is to find the right problem where the new discovery can be used. Mechanistic research often leads to great discoveries sitting there waiting for somebody to find a way to use them. By far, most of the new knowledge is generated because of the mechanistic motivations of scientists exploring new explanations to understand better the basis of life. In fact, in general scientists do not care too much about market access and the likes. However, mechanistic research is probably the only effective path to real breakthroughs, something that was recognized in 1945 in Science, the endless frontier, a document that lead to the creation of the National Science Foundation, the National Institutes of Health  and the Defense Advanced Research Projects Agency  in the US. The idea-force behind this landmark document was the following (quoted literally): “To discover is to obtain for the first time sight or knowledge of some fact or principle hitherto unknown. Discovery cannot be achieved by directive. New products and new processes do not appear full-grown. They are founded on new principles and new conceptions, which in turn are painstakingly developed by research in the purest realms of science.”  

 

While the pull approach has been the main driver of the biopharma industry over the last fifty years, its perceived increasing lack of productivity combined with the massive amount of mechanistic knowledge that is permanently being generated in academic institutions are the basis of a very clear trend that permeates modern pharma. Big or small, almost everybody in the industry is trying to fish in the open innovation space, adding the push strategy to their business models with more or less fortune.

 

When we started Spherium Biomed we decided to stay in the push side. Our key assumption was that academic research was mechanistically driven, and that even when the results were presented as a consequence of a problem-solving process, in the great majority of cases the problem itself was badly defined and that just the right definition of the problem to solve lead to a significant improvement (or refutation) of the potential value of the research from the applied point of view.

 

Defining the right problem (in our process, the right Target Product Profile, TPP) is the very first step in our company when we start the evaluation of an academic technology. If we are able to define the TPP we have the most important thing that any new project can have: a defined goal (in engineering language, the specifications of the product). Then we can start thinking in a development plan (basically a development plan should aim to fill the gaps between the technology at time zero and the technology at TPP stage). If we can deliver a development plan, that means that have identified all the required providers and collaborators, so we have budgets and calendars. If those fit our budgetary and time constrains, then we have a project and we try to negotiate a license to be able to develop and commercialize the technology. If not, we don’t go for it. As simple and as complex as that.  

 

13 DE ENERO DEL 2016

SPHERIUM INICIA UN ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA DE UN PRODUCTO PARA TRATAR EL DOLOR EN LA ARTICULACIÓN DE LA MANDÍBULA

Spherium ha iniciado la inclusión de pacientes en un ensayo clínico para evaluar la eficacia de SP12006 para el tratamiento del dolor agudo asociado a los trastornos temporo-mandibulares. El ensayo incluirá 96 pacientes provenientes de cinco centros especializados de ámbito nacional. Los resultados se conocerán durante 2016.

Los trastornos temporo-mandibulares son un problema significativo de salud pública y son la segunda causa de dolor e incapacidad de origen musculo-esquelético tras el dolor crónico de espalda. La complejidad de la articulación temporo-mandibular y la diversidad de causas que provocan el trastorno explica que no exista una medicación específica, con tratamientos sintomáticos que son poco satisfactorios.

SP12006 ha sido íntegramente desarrollado por Spherium a partir de la investigación realizada por un asesor clínico de su red internacional. Se trata de una combinación novedosa, patentada, de productos conocidos que se dirigen a los diferentes agentes causales del trastorno.  Se prevé también iniciar el desarrollo del producto para el tratamiento del dolor muscular asociado a la práctica deportiva intensa. 

Si los resultados fueran positivos, SP12006 podría llegar a ser el primer fármaco disponible  para el tratamiento del dolor agudo asociado a los trastornos temporo-mandibulares. Casi 5 millones de personas en Europa y en Estados Unidos necesitan algún tipo de tratamiento. Sólo en España el nuevo fármaco podría beneficiar a unas 200.000 personas. Los tratamientos actuales se dirigen al manejo del dolor y restablecimiento de la función, pero no acaban de resolver los problemas en un porcentaje muy significativo de los pacientes. No existen pautas claras de tratamiento farmacológico. Se emplean férulas de uso nocturno, analgésicos, anti-inflamatorios, relajantes musculares, antidepresivos, llegándose al uso de opioides e incluso cirugía en los casos más graves. Además, SP12006 podría ser útil para evitar el dolor y malestar muscular asociado a la práctica deportiva intensa.

Para Luis Ruiz-Ávila, Director General de Spherium, el inicio de este ensayo clínico, el segundo ensayo en pacientes que comienza la empresa, es un hito importante que demuestra la validez de su modelo de negocio. Dice Ruiz-Avila: “con el inicio de este ensayo clínico demostramos que es posible desarrollar fármacos innovadores, que resuelven problemas de salud importantes, partiendo del conocimiento generado en entornos académicos. Siguiendo el mismo modelo actualmente estamos desarrollando otros proyectos para entrar en fases clínicas de eficacia, consolidando así el trabajo de investigación realizado en los últimos años tanto por la empresa como por los investigadores que originaron en su momento el conocimiento de base para diseñar los nuevos medicamentos.

14 DE OCTUBRE DEL 2014

Aquilon gana el premio Cinco Días

Aquilón Cyl SL ha sido elegida como empresa más innovadora por los premios Cinco Días a la innovación empresarial en su edición de 2014. El premio reconoce el modelo de negocio de la compañía, basado en transformación de conocimiento académico veterinario en productos competitivos. La creación de Aquilón, concebida e impulsada por Spherium Biomed 2012 (el nombre de la compañía era Janus Developments) para canalizar el desarrollo de tecnologías dirigidas a la mejora de la productividad animal que habíamos adquirido o detectado en diferentes universidades, es un ejemplo de éxito del modelo de negocio de Spherium Biomed.  En la actualidad Spherium dirige la empresa y participa en su capital. Gracias a la creación de Aquilón se ha logrado movilizar hasta el momento 1,7 millones de euros de capital privado para completar el desarrollo de tres productos innovadores con alto impacto potencial en la mejora de la productividad en la industria porcina.  

http://cincodias.com/cincodias/2014/10/10/sentidos/1412971029_355536.html

  • 12 DE JUNIO DEL 2017

    Their time in our hands

    It was 2010 and we had just closed a consortium agreement to invest 2 million euros in a pre-clinical project to treat Lou Gehrig’s disease (ALS, or ELA in Spanish). We had licensed the technology from the University of Zaragoza (Spain)...

  • 27 DE NOVIEMBRE DEL 2013

    Janus y Ferrer crean Spherium

    Janus establece una alianza estratégica con Ferrer para implementar un nuevo modelo de I+D en la Industria Farmacéutica Española.
    Con la creación de Spherium, Janus Developments valida su modelo de negocio y Ferrer diversifica sus actividades...

12 DE JUNIO DEL 2017

Their time in our hands

It was 2010 and we had just closed a consortium agreement to invest 2 million euros in a pre-clinical project to treat Lou Gehrig’s disease (ALS, or ELA in Spanish). We had licensed the technology from the University of Zaragoza (Spain) one year before. The consortium creation and financing was great news, so we distributed a press release. Immediately we got a call from one patients association that wanted to know more about the project. Of course we accepted and explained the full project to two members of the association, who came to our offices in downtown Barcelona. They were assisted by caregivers, since they seldom could move but their fingers to manage their electric wheel-chairs. They understood the very pre-clinical, almost research nature of the project and how far it was from becoming a clinical reality, but nevertheless they expressed all their support and offered to help us in everything that they could.

At the end of the meeting they gave us a poisoned gift (this was their exact definition of the little box they handled to us). The box contained a sand clock, the symbol of the association. They always display it horizontally, trying to stop the sand grains going through the hole, trying to delay or to stop the non-stoppable disease progression. The clock had a little silver plaque at the top. The plaque read Our time is in your hands.

When talking about mission, vision, values and so on we always look for those catchy buzzwords that tend to describe too much in too little space. Turn knowledge into products sounds nice, increase shareholders value sounds even better, be the leaders in whatever... But in most of the companies in the biomedical space there is a component that goes beyond shareholder value or commercial leadership. Our raw material is biomedical knowledge. And when you play with biomedical knowledge there is always somebody down the road that is thinking my time is in their hands (as were our friends from the ALS patient association). Big thing, big privilege and huge responsibility.

Of course we need to create value for our shareholders; of course we need to play the leadership card in turning knowledge into meaningful products. But, we at Spherium Biomed firmly believe that we need to do it because is the only way to fulfil the enormous ethical challenge posed by the time in your hands plaque in the sand clock of the local ALS patient association. We are firmly committed to do our best.

The project referred in this note was coded JAN0913, which we cancelled last year due to insufficient systemic efficacy at the pre-clinical level. Despite this setback, we keep fighting relevant unmet needs as for example cancer-related mucositis, a condition that affects up to 90% of patients with head and neck cancer receiving radio-chemotherapy and up to 30% of women with breast cancer treated with chemotherapy. The condition has a tremendous impact in the quality of life, becoming sometimes life-threatening to the extent to force to stop the cancer treatment. We have great hopes in this project (SP13004). Results expected 1Q in 2018, fingers crossed.

Luis Ruiz-Ávila, CEO of Spherium Biomed

27 DE NOVIEMBRE DEL 2013

Janus y Ferrer crean Spherium

Janus establece una alianza estratégica con Ferrer para implementar un nuevo modelo de I+D en la Industria Farmacéutica Española.
Con la creación de Spherium, Janus Developments valida su modelo de negocio y Ferrer diversifica sus actividades de I+D para adaptarse eficientemente a las necesidades actuales del mercado