Paris (France) and Cambridge (Massachusetts, United States), July 10, 2023 – 7:00 a.m. – Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a biotechnology company clinical stage specializing in the development of treatments that aim to slow the degenerative processes associated with aging and improve the functional outcomes of patients suffering from age-related diseases, including respiratory failure in patients suffering from COVID-19 , announces today that it has submitted the application for authorization on the FDA (Food and Drug Administration) portal to launch its SARA-31 program in the United States, the very first phase 3 study in sarcopenia.
The launch of the Phase 3 program follows the promising results obtained during the SARA-INT phase 2b study and discussions with health authorities in 2022. Based on the results of the previous study and feedback from the he US government agency, Biophytis is starting its phase 3 program by filing the first phase 3 (SARA-31) authorization request in sarcopenia with the FDA. This application follows the one recently filed in Europe with the EMA (European Medicines Agency).