Biophytis Shares Gain After Detailed Data From Pivotal COVID-19 Treatment Study
- Biophytis SA has released the full results from its phase 2-3 COVA study evaluating Sarconeos (BIO101) for COVID-19-related respiratory failure.
- The study's objective was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID, in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure requiring high flow oxygen or mechanical ventilation, and death.
- On respiratory failure or early death, post-hoc analyses show a significant reduction with Sarconeos (BIO101) in the risk of early death or respiratory failure at day 28 by 45% in the Intent-To-Treat (ITT) population and by 53% in the Per Protocol (PP) population.
- In the primary analysis, Sarconeos reduced by 39% the risk of respiratory failure or early death at 28 days compared to the placebo.
- On mortality follow-up over 90 days, the risk of death was reduced with Sarconeos by 43% in the ITT population and 70% in the PP population.
- Sarconeos (BIO101) has a good safety profile, with a lower proportion of patients with adverse events compared to placebo (57% vs. 64%), in particular, a lower frequency of serious, primarily respiratory, adverse events (25% vs. 31%).
- The company aims to file for conditional marketing authorization (Europe) and emergency use authorization (U.S., Brazil) as soon as possible in 2023.
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