Biophytis SA, a clinical-stage biotechnology company specialized in the development of drug candidates for the treatment of aged related diseases, including neuromuscular diseases, today announces that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to proceed with its clinical development program COVA.

This Phase 2/3 program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19.Sarconeos (BIO101), company's leading drug candidate, is a small molecule, administered orally, currently in clinical Phase 2b in sarcopenia (SARA-INT) in the United States and Europe. A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The company plans to start the clinical development (MYODA) in H2 2020.

Sarconeos (BIO101) is also being developed as a treatment for COVID-19. The Company has received approval from FAMHP (Belgium), the MHRA (UK) and US FDA to begin the Phase 2/3 clinical trial (COVA) to evaluate Sarconeos (BIO101) as a potential treatment for respiratory failure associated with Covid-19. The Company also filed a clinical trial application with the French regulatory agency, ANSM in France.

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 pivotal, international clinical trial will be conducted in two parts, the first of which has the objective to assess treatment safety and provide an indication of activity of Sarconeos (BIO101), in 50 hospitalized COVID-19 patients suffering from acute respiratory deficiency. The second part of the study will investigate the efficacy of Sarconeos (BIO101) on the respiratory function of around 300 additional patients.

Stanislas Veillet, CEO of Biophytis, said: “There is an urgent need for therapies to help patients with COVID-19 Acute Respiratory Distress Syndrome (ARDS) given the continuing rapid spread of SARS-CoV-2 and limited therapeutic options. With FDA clearance, we intend to initiate a clinical trial to evaluate Sarconeos (BIO101) in patients with acute respiratory failure associated with COVID-19. The elderly and those with comorbidities are at highest risk of death from SARS-CoV-2. We have already initiated the work to start this key Phase 2/3 trial as soon as possible in the US, and in the European countries where we received approval, and will update the market shortly on our planned timelines.”

Biophytis SA is a clinical-stage biotechnology company specialized in the development of drug candidates to slow down degenerative processes and improve functional abilities in patients with age-related diseases, including neuromuscular diseases.