Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) is thrilled to announce its recent filing for a pre-submission meeting with the European Medicine Agency (EMA) to discuss the potential conditional Marketing Authorisation (cMA) of their therapeutic drug Sarconeos (BIO101) for the treatment of severe COVID-19 cases. This remarkable development marks a major milestone in their mission to slow the degenerative effects of aging and alleviate suffering caused by the global pandemic.
Sarconeos (BIO101) is set to take the next major step in the regulatory process by seeking conditional Marketing Authorisation in Europe for its use in treating severe forms of COVID-19. With this in mind, the company plans to file a request for a pre-submission meeting with the FDA in the US in order to pursue Emergency Use Authorisation (EUA) in the coming quarter. This is set to be a major milestone in the journey towards providing a much-needed treatment for this debilitating disease.
Biophytis recently held a meeting with the French Health Authority to discuss an application for early access to Sarconeos (BIO101) for those hospitalized with severe COVID-19. An application is ready to be filed this quarter with the goal of treating the first patients in the second half of 2023 if all goes according to plan.
The meeting with the EMA will determine the eligibility and conditions for a conditional marketing authorisation application at the European level. Depending on EMA’s recommendations, Biophytis hopes to file a conditional marketing authorisation in either the second half of 2023 or the first half of 2024. Above all, their main goal is to help those in France, Europe and the US/Brazil who are suffering from severe forms of COVID-19 and are at risk of respiratory failure or death.
Biophytis SA is a clinical-stage biotechnology company with a pioneering mission: to slow down the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases.
Our lead molecule drug candidate, Sarconeos (BIO101), completed a Phase 2 clinical trial as a treatment for sarcopenia in the United States and Europe (SARA-INT), and obtained positive results from a Phase 2-3 clinical trial (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America and the United States.
We are also developing a pediatric formulation of Sarconeos (BIO101) for the treatment of Duchenne Muscular Dystrophy (DMD). Based in Paris, France, and Cambridge, Massachusetts, our ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and ADSs (American Depositary Shares) are listed on Nasdaq Capital Market. We are dedicated to helping people live longer, healthier, and happier lives.