Biophytis SA, a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces that patient recruitment at most clinical centers in Brazil and the United States will begin for Part 2 of its COVA Study assessing Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19.
Enrollment for Part 1 of the COVA Study has been completed with 50 patients recruited in 4 countries: Brazil, the USA, Belgium, and France. Following the Data Monitoring Committee (“DMC”) recommendation to begin the recruitment for Part 2, authorization is being obtained from regulatory authorities (national regulatory agencies and/or central IRB and/or local Ethics Committees) in Brazil and the USA for the start of Part 2. Similar authorizations are being pursued in France, Belgium and the UK.
Stanislas Veillet, Chief Executive Officer of Biophytis, said: “We are extremely pleased to start recruiting patients for Part 2 at most clinical centers in Brazil and the USA.” He added: “There continues to be an unmet need for new COVID-19 treatment options for elderly patients, or patients with co-morbidities, who will continue to be at high risk of developing severe respiratory manifestations requiring hospitalization.”
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, tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to 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.
Part 2 of the COVA Study is a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function from 310 COVID-19 patients (including the 50 patients from Part 1 of the study). The full study results (Part 1 and Part 2) are expected in Q2 2021, subject to any delays in patient recruitment or retention, interruptions in sourcing or supply chain, regulatory authorizations, COVID-19-related delays, and the impact of the current pandemic