Biophytis Receives MHRA Approval to Initiate the COVA Clinical Trial in the UK with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Paris, (France), Cambridge (Massachusetts, United States), June 11, 2020, 8:00 a.m. CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company specialized in the development of drug candidates for treatment of aged related diseases, including neuromuscular diseases, today announces that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with its clinical development program COVA. This program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19.

The COVA clinical program is designed to evaluate the efficacy and safety of Sarconeos (BIO101) as a treatment of the respiratory deterioration in COVID-19 patients with severe respiratory failure. This Phase 2/3, randomized, double-blind, placebo-controlled, adaptive and group sequential study assessing Sarconeos (BIO101) in patients infected with SARS-CoV-2 is expected to start in the coming weeks in the UK, upon approval of the relevant ethics committees. This pivotal, international clinical trial will be conducted in two parts, the first of which has the objective to assess treatment safety in 50 hospitalized COVID-19 patients suffering from acute respiratory deficiency, and to estimate the number of patients to be recruited in the second part to detect a significant effect of Sarconeos (BIO101) on the respiratory function.

Stanislas Veillet, CEO of Biophytis, said: “We are very pleased to have received approval from the MHRA to start COVA in the UK. The Coronavirus SARS-CoV-2 can cause Acute Respiratory Distress Syndrome (ARDS) by disrupting the renin angiotensin system (RAS), which has a key role in regulating respiratory function. SARS-CoV-2 enters cells in various tissues, particularly pulmonary tissues, using as a receptor the Angiotensin 2 Converting Enzyme (ACE-2), a key enzyme in the RAS, thus inhibiting the system’s protective arm. Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS.

Based on its mode of action we are confident that Sarconeos (BIO101) could become an important - potentially life-saving - treatment for patients with acute respiratory failure associated with COVID-19. “