- Biophytis SA (NASDAQ: BPTS) said that it is currently assessing FDA comments and recommendations and preparing to submit Phase 2-3 trial designs for sarconeos (BIO101) trial in sarcopenia.
- Enrollment is expected to start in 2H of 2022 in the SARA Phase 2 trial.
- In October 2021, sarconeos at the highest dose of 350 mg bid demonstrated an increase of 0.09 meters per second (m/s) in the FAS population and 0.10 m/s in the PP population compared to placebo 400MWT in gait speed after six months of treatment.
- Due to pandemic-related restrictions, 106 patients could perform the 400m walk test at the end-of-treatment visit, which was the primary endpoint of our study, which resulted in a 55% loss of efficacy data.
- In January this year, the Company met FDA for conducting additional dose-finding and further definition of the proposed population and indication, CMC (chemistry, manufacturing, and control section) data to be submitted, and the regulatory non-clinical plan.
- The Company anticipates having other discussions with the FDA in Q3 of 2022 and EMA in H1 2022 to get scientific advice.
- Related: Why Are Biophytis Shares Trading Higher During Premarket Trading?
- For the COVID-19 trial (COVA), the Company has stopped patient enrollment and is proceeding to close its clinical centers in Q2 2022 to report the study results in Q3 2022.
- The initial target for the study was the recruitment of 310 to 465 patients. Since April 2020, 237 patients meeting the study criteria have been enrolled.
- The Company noted that since the end of 2021, global immunity in Europe, the US, and Brazil, and vaccination campaigns have progressed.
- Price Action: BPTS shares are down 13.50% at $2.18 during the premarket session on the last check Thursday.
Read at Benzinga