BPTS - Biophytis details COVID impact on clinical trials for lead asset

Biophytis (NASDAQ:BPTS) has lost ~18% in the pre-market Thursday after the clinical-stage biotech highlighted the impact of COVID-19 on its ongoing clinical studies for the lead candidate Sarconeos (BIO101) in sarcopenia (SARA) and COVID-19 (COVA). At the end-of-treatment visit in the SARA trial, only 106 patients had performed the 400m walk test, the primary endpoint of the study. That has led to a 55% of loss of efficacy data, the French company said. Biophytis (BPTS) is currently in discussions with the U.S. regulators for a phase 2-3 design targeting the first patient in by 2H 2022. “We are now exchanging with FDA and soon with EMA for the preparation our phase 2-3 study. Assuming authorizations are obtained, we expect to have our FPI by end of H2 2022," Biophytis (BPTS) Chief Executive Stanislas Veillet, said. In addition, the company has witnessed a slowdown in enrollment for phase 2-3 COVA trial, which is designed

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Biophytis details COVID impact on clinical trials for lead asset