Biophytis Shares Fall As It Stops Enrollment In Sarconeos COVID-19 Trial, Data Expected In Q3 2022

Biophytis SA 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.

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Biophytis Shares Fall As It Stops Enrollment In Sarconeos COVID-19 Trial, Data Expected In Q3 2022

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