Biophytis announces positive final results of the phase 2-3 COVA study with Sarconeos (BIO101) in severe COVID-19

Biophytis / Key word(s): Miscellaneous Biophytis announces positive final results of the phase 2-3 COVA study with Sarconeos (BIO101) in severe COVID-19 02-Feb-2023 / 08:00 CET/CEST

Biophytis announces positive final results
of the phase 2-3 COVA study with Sarconeos (BIO101)
in severe COVID-19

 

 

• COVA study met primary end point with 44% significant reduction in the risk of respiratory failure or early death

 

• Filing for Early Access Programs to Sarconeos (BIO101) is being initated while preparing for Marketing Authorisation in Europe and the USA

 

 

Paris (France), Cambridge (Massachusetts, U.S.), February 2, 2023, 8am CET – Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS) (the “Company” or “Biophytis”), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today released the final results from its phase 2-3 COVA clinical study evaluating Sarconeos (BIO101) in the treatment of COVID-19-related respiratory failure. Biophytis announces today final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022. The final analysis demonstrates that COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with positive Post-Hoc analysis released on November 3, 2022.

Stanislas Veillet, CEO of Biophytis, said: " The COVA study is positive, with a statistically significant reduction of 44% in the risk of respiratory failure or early death, demonstrating the therapeutic potential of Sarconeos (BIO101) in the treatment of severe COVID-19. This huge success is the result of Biophytis scientific excellence and hard work of the clinical and medical teams involved in the COVA clinical study in France, Belgium, the USA and in Brazil. This is tremendous news for patients worldwide, especially for the elderly with co-morbidities, who are at high risk of developing severe COVID-19, despite the great progress made in vaccination and anti-viral treatments now available. While there is a resurgence of COVID-19 patients in China and still unacceptable levels of patients dying from COVID-19 in Europe, the USA and Brazil, Sarconeos (BIO101) may offer an effective therapeutic option to reduce further the threat of COVID-19 pandemic. We are now accelerating the start of our Early Access Program, with the target to give access to Sarconeos (BIO101) in Brazil and France in the second half of 2023, while preparing for filing conditional Marketing Authorisation (CMA) in Europe and Emergency Use Authorization (EUA) in the USA. "