Following the release of the findings of clinical research, Biophytis S.A. (NASD: BPTS) is climbing the charts today, rising 24.36% to trade at $0.7337 at the most recent check in premarket activity.
What research findings have BPTS made public?
The complete findings of Biophytis’ phase 2-3 COVA clinical research assessing Sarconeos (BIO101) for the management of COVID-19-related respiratory failure were made public. The study’s goal was to determine if Sarconeos (BIO101), 350 mg BID, was effective and safe for use in hospitalized COVID-19 patients with hypoxemia who were at danger of dying or needing high-flow oxygen or mechanical ventilation. The primary study examined the proportion and duration to the beginning of these adverse events at 28 days, which corresponds to the maximal treatment length, with follow-up on mortality and safety for at least 90 days.
The 233 patients who underwent treatment (ITT population) were, on average, 63 years old, 64% of them were men, and they had been infected with the major SARS-Cov-2 strains when they were recruited from locations in Europe, the US, and Brazil between Q3 2020 and Q1 2022. Due to sluggish recruitment, the experiment was halted early before enrolling the intended 310 participants.
Post-hoc statistical analyses have been carried out to re-estimate the impact of Sarconeos (BIO101) on the risk of early death or respiratory failure at day 28 (the study’s primary endpoint) and death at day 90 in the ITT and PP populations since the study’s top-line results have been reported and because the study was underpowered.
What BPTS has been observed?
Sarconeos (BIO101) has an excellent safety profile, with a lower percentage of patients experiencing side effects compared to placebo (57% vs. 64%), and in particular, a reduced incidence of major adverse events (25% vs. 31%), which are primarily respiratory in nature. In the first half of 2023, Biophytis plans to disclose the findings in full at future scientific conferences and in a peer-reviewed publication.
The therapeutic potential of Sarconeos (BIO101) in the care of hospitalized patients with severe COVID-19 is substantially backed by these post-hoc evaluations. Impressive is the more than 40% decrease in the risk of respiratory failure and mortality. These findings confirm our commitment to continue developing Sarconeos (BIO101) for this indication, providing hospitalized patients with a therapeutic option as COVID-19 spreads throughout the country. These findings go above and beyond expectations for the effect size of BIO101 used in the sample size calculation of the study.
How BPTS will move further?
In the upcoming months, BPTS will begin discussing these findings with regulatory organizations and health authorities, notably in Europe, the US, and Brazil. As soon as feasible in 2023, Biophytis (BPTS) plans to submit applications for conditional marketing permission (Europe) and emergency use authorization (USA, Brazil).