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1 OCTOBER 2018

Spherium completes Phase II clinical trial on Cyclatop© for atopic dermatitis

Spherium Biomed presented positive results from its Phase II clinical trial on an innovative treatment for atopic dermatitis (Cyclatop©) at the Annual Congress of the European Academy of Dermatology and Venereology (EADV), held 12 to 16 September in Paris.
The double-blind, placebo controlled, bilateral right-left study (each patient got the placebo on one side and Cyclatop© on the other) was conducted at eight hospitals in Spain. It showed that Cyclatop© is safe, well tolerated by patients with mild-to-moderate atopic dermatitis and highly effective in reducing the symptoms of the disease, including itching.
The value Cyclatop© will bring to the market is that it is a topical spray with cyclosporin, a drug widely used and highly effective in treating severe atopic dermatitis. However, it is only available to be administered orally or intravenously, with renal toxicity issues. With Cyclatop©, as it is a localised treatment administered only to the affected areas of skin, the cyclosporin in blood levels and adverse effects are kept to a bare minimum.
Treatment with Cyclatop© had no noteworthy adverse effects and was well tolerated by patients (87% considered it quite acceptable or very acceptable), particularly paediatric patients, in which the disease is more prevalent.
This is the fourth pharmaceutical product Spherium has in the clinical phases and its third to successfully complete phase II efficacy trials. The global market Cyclatop© targets is worth €6 billion. According to Spherium CEO Luis Ruiz-Ávila, “The next milestone for this project is to get the right partners to ensure development of Cyclatop© through to registration and commercialisation worldwide. We believe the product could hit the market by 2024.”
Over 54 million people with atopic dermatitis
Atopic dermatitis is often considered a minor medical issue by those who don’t have it. Nevertheless, given its high prevalence (particularly among children), recurring nature, persistence and discomfort, it is a significant public health issue with a significant impact on quality of life for patients and their families, in addition to the associated costs for families and healthcare systems.
Furthermore, it is becoming more prevalent: estimates show that there will be 54 million people in the world affected by this condition by 2020. There is no single cause of the disease and, although there are numerous therapeutic options, it is a medical need that has not been well met. Treatments range from non-pharmacological emollients to latest-generation immunosuppressants, as well as cortisone and other drugs that cover a wide range of mechanisms of action.
There is a general consensus that more tools are needed to improve treatment.