Noticias sobre Spherium

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5 DE OCTUBRE DEL 2018

Spherium completes Phase I clinical trial on Cilakin© to prevent AKI

Spherium Biomed has completed the Phase I clinical trial on Cilakin© (SP15016) to prevent acute kidney injury (AKI). This is a recurring problem, as it is a common side effect of chronic pathologies, mainly diabetes, and pharmacological and medical treatments. Mortality can reach 70% of patients in the case of AKI from sepsis.

To respond to this unmet medical need, Spherium is developing Cilakin© to prevent renal toxicity secondary to the administration of drugs, contrast agents, surgical procedures and septicaemia.

It has been administered to 18 volunteers in three doses to explore tolerability, pharmacokinetics and cardiac safety in preparation for future administration to patients. The Cilakin© infusion was well tolerated, with no adverse events observed, and pharmacokinetics well characterised. “It could become the first standard preventive treatment for AKI of any origin,” remarked Dr Montserrat Cano, senior project manager at Spherium.

Cilakin© is based on cilastatin, a product that has been administered to humans for a long time in combination with antibiotics, with comprehensive information on its safety profile and pharmacokinetic attributes. This greatly diminishes the risks and uncertainties inherent in any new clinical development.

The nephroprotective effects of cilastatin were discovered through more than ten years of pioneering research led by the team of doctors Alberto Tejedor and Alberto Lázaro at Gregorio Marañón University Hospital in Madrid. In 2015, Spherium acquired the exclusive rights to develop and commercialise the intellectual property related to the use of the product. Once the safety and pharmacokinetics of the drug have been established, the next step is to start clinical trials in patients at risk of developing AKI.

This is the fourth clinical programme set forth by Spherium over the past 3 years. According to Luis Ruiz-Ávila, CEO of the company, “It consolidates the company’s business model, which aims to develop biomedical products by sourcing scientific knowledge and intellectual property generated at universities and research centres anywhere in the world.”

3 million patients each year with AKI

In the process of eliminating the body’s waste, the kidneys filter 200 litres of blood a day to produce about 2 litres of urine. Patients with AKI can no longer eliminate waste, which can trigger a chronic illness or even death. The most important causes of AKI are sepsis, cardiovascular surgery, exposure to nephrotoxic drugs and trauma. Patients with AKI who need dialysis have the worst prognosis. Currently, the only treatment option for AKI is dialysis for the most severe cases and supportive treatment until spontaneous resolution in milder situations. There are no approved medications to prevent this condition.

Hospital-acquired AKI affects about 3 million patients each year in Europe, the United States and Japan, and is associated with the mortality of some 700,000 patients. It can occur in up to 4% of hospital admissions and 40% of admissions in intensive care. Depending on the severity and cause of the kidney injury, mortality ranges from 10% to 70%.