BIOPHYTIS SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), (“BIOPHYTIS” or the “Company”), a clinical-stage biotechnology company focused on the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces it has recruited the 155th participant for Part 2 of its COVA Phase 2-3 study of Sarconeos (BIO101) in patients infected with COVID-19.
Recruitment of the 155th participant allows for the independent Data Monitoring Committee (DMC) to conduct its second interim analysis, based on safety and efficacy data, for the continuation of the trial in case of favorable results. The Company is to report the recommendations of the DMC based on its review of the second interim analysis results by the end of Q2 2021.
The DMC previously delivered a favorable opinion in March on the safety of Sarconeos (BIO101) in COVID-19 and recommended the continuation of the study into Part 2, following the scheduled interim analysis of the 50 participants in Part 1 of the COVA study.
Recruitment into Part 2 of the study continues to proceed in France and Brazil to complete enrollment of 310 participants, with the aim of filing for Emergency Use Authorization with the US Food and Drug Administration (FDA) and Conditional Approval with the European Medicines Agency (EMA) in Q3 2021. The final study results are expected in Q3 2021, subject to any COVID-19-related delays and the impact of the pandemic.
Stanislas Veillet, President and CEO of BIOPHYTIS, said: “Completion of recruitment of the 155th patient is an important milestone for BIOPHYTIS as we will be able to measure the therapeutic potential of Sarconeos (BIO101) in COVID-19. We are now looking forward to the second interim analysis, and hope the DMC will recommend the continuation of our Phase 2-3 COVA trial upon favorable review of the safety and efficacy data.”
The COVA clinical program (clinicaltrials.gov identifier NCT04472728) is a global, multicenter, double-blind, placebo-controlled, group-sequential and adaptive design two-part study. This Phase 2-3 study assesses Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19. The 155 participants were recruited in 34 centers in 4 countries: the US, Brazil, France and Belgium.
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 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 participants, or up to 465 participants, including the 50 participants from Part 1 of the study.
The final sample size will depend upon DMC recommendations from the second interim analysis.