Biophytis Announces Expansion of Patient Recruitment for Part 2 of the Phase 2-3 COVA Trial (“COVA Study”) Following Regulatory Authorities Approvals in France and Belgium

• Clinical centers in France and Belgium will begin recruitment for Part 2 of the COVA Study following authorization from Regulatory Authorities
• These approvals follow the previous authorizations obtained from Brazil and the United States in most clinical centers
• Interim Analysis of Part 1 is expected in Q1 2021
• Results from the full study (Part 1 and Part 2) are expected in Q2 2021

PARIS and CAMBRIDGE, Mass., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqGS: BPTS; Euronext Growth Paris: ALBPS), 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 that patient recruitment will begin in France and Belgium for Part 2 of its COVA Study assessing Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19.

Following the Data Monitoring Committee (“DMC”) recommendation to begin the recruitment for Part 2, authorization was obtained from Regulatory Authorities (national regulatory agencies and/or central IRB and/or local Ethics Committees) in Brazil and the USA for most clinical centers in the two countries for the start of Part 2. Similar authorizations are now obtained in France and in Belgium, from the respective Regulatory Authorities.

That brings to four the number of countries in which the COVA Study is now recruiting for Part 2: France, Belgium, Brazil and the United States, following the completion of patient enrollment for Part 1, which is now achieved with 50 participants.

Stanislas Veillet, Chief Executive Officer of Biophytis, said: “We are extremely pleased that Part 2 of the COVA Study has now also been authorized in France and Belgium.”

The COVA Study (clinicaltrials.gov identifier: NCT04472728 and EudraCT identifier: 2020-001498- 63) is a global, multicenter, double-blind, placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3 study assessing 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, and tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations of COVID-19. The interim analysis of Part 1 is expected in Q1 2021, subject to any COVID-19 related delays and the impact of the current pandemic on our operational capabilities.