Biophytis Reports Positive Post-hoc Analysis of The Phase 2-3 COVA Clinical Study Strongly Supporting Therapeutic Potential of Sarconeos (BIO101) In COVID-19

• A reduction in the risk of early death or respiratory failure at day 28 of 45% in the Intent-To-Treat (ITT) population and 53% in the Per Protocol (PP) population
• A reduction in the risk of death at day 90 of 43% in the ITT population and 70% in the PP population
• The start of regulatory development of Sarconeos (BIO101) targeting conditional and emergency use marketing authorisations in 2023

Excerpt from the Press Release:

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / November 3, 2022 / 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 full results from its phase 2-3 COVA clinical study evaluating Sarconeos (BIO101) in the treatment of COVID-19-related respiratory failure.

The objective of the study 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. The proportion and time to onset of these negative events were studied at 28 days in the primary analysis, corresponding to the maximum treatment period, with follow-up of mortality and safety for at least 90 days.

The 233 treated patients (ITT population) were 63 years old on average, 64% of the patients were male, recruited in centers in Europe, the US and Brazil between Q3 2020 and Q1 2022, infected with the main SARS-Cov-2 variants.The trial ended early before reaching the 310 patients originally planned, due to stalled recruitment. The sub-population of patients without major protocol deviations (PP sub-population) included 180 patients with similar baseline demographics and disease characteristics as the ITT population. Since the top line results of the study were reported and because the study was underpowered, post-hoc statistical analyses have been performed to re-estimate the effect of Sarconeos (BIO101) on the risk of early death or respiratory failure at day 28 (primary endpoint of the study) and death at day 90 in the ITT and PP populations.

On respiratory failure or early death, post-hoc Kaplan-Meier analyses show a significant reduction with Sarconeos (BIO101) in the risk of early death or respiratory failure at day 28 by 45% (p=0.037) in the ITT population and by 53% (p=0.051) in the PP population.

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