Biophytis to meet with FDA to advance Sarconeos (BIO101) development in Sarcopenia from Phase 2 to Phase 3
- Following Phase2b/SARA-INT clinically meaningful results, Biophytis is starting first regulatory activities to advance from Phase 2 to Phase 3 development
- A Type B/End-of-Phase 2 meeting is planned with FDA (Food and Drug Administration) on January 24th, 2022, to discuss these results and the Phase 3 protocol design
- Assuming potential agreement and approval from US authorities Biophytis intends to initiate its Phase 3 program in Sarcopenia in H2 2022