Benzinga | Mar 22, 2021 05:39AM EDT

BIOPHYTIS Independent Data Monitoring Committee Delivered Favorable Opinion for its Phase 2-3 COVA Study on COVID-19

BIOPHYTIS SA (NASDAQ:BPTS) announces that the independent Data Monitoring Committee (DMC) for the COVA study has delivered a favorable opinion on the safety of Sarconeos (BIO101) in patients infected with COVID-19, following the scheduled interim analysis of the 50 participants from Part 1 of the study, as well as the progression of patients enrollment, which has now reached 97 of the 155 planned for the second interim analysis.

A total of 28 clinical centers of the 30 targeted are now opened and recruiting in the United States, Brazil, France and Belgium. Upon the second interim analysis, based on the safety and efficacy data from 155 patients, the DMC will re assess the total size of the cohort, estimated today at 310 patients, and the continuation of the trial.

Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: "In the persistent pressured healthcare context of COVID-19, we are extremely pleased with the opinion delivered by the DMC on the safety of Sarconeos (BIO101) in the framework of our COVA trial. This opinion allows us to push our mission forward with continued recruitment into Part 2 of the COVA study. We have now enrolled 97 out of the targeted 155 participants planned for the second interim analysis. Our 28 sites are recruiting in the United States, Brazil, France and Belgium. Our next milestone is now the second interim analysis, where we will get from DMC the green light for continuing our trial, as well as the final number of patients needed for the study".

The COVA clinical program (clinicaltrials.gov identifier NCT04472728) is a global, multicenter, double-blind, placebo-controlled, group-sequential and adaptive design two-part study. It is a Phase 2-3 study that assesses Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19

Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19.

Part 2 of the COVA Study is a Phase 3 randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function of 310 COVID-19 patients (including the 50 patients from Part 1 of the study).

The study results (Part 1 and Part 2) are expected in Q2 2021, subject to any COVID-19-related delays and the impact of the current pandemic.