MAY 15, 2023
Biophytis has filed with the EMA for authorization to initiate SARA-31 phase 3 study in sarcopenia Biophytis announced that it has submitted the application for Clinical Trial Authorization (CTA) to initiate SARA-31, the first phase 3 study in sarcopenia, on the European portal of the EMA (European Medicines Agency). The launch of the Phase 3 program follows encouraging results from the SARA-INT Phase 2b study and interactions with health authorities in 2022. Based on the Phase 2b results and feedback from the agencies, Biophytis is starting its Phase 3 programme by filing the first Phase 3 (SARA-31) application in Europe.