In today’s premarket trading, Biophytis S.A. (NASD: BPTS) is soaring on the charts, up 28.53% to trade at $0.45 at the last check. Despite the dearth of recent news, the price of BPTS stock increased, therefore recent events may be helpful in providing information about the clinical-stage biotechnology business.
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What recently occurred?
The complete findings of Biophytis’ phase 2-3 COVA clinical research assessing Sarconeos (BIO101) for the treatment of respiratory failure brought on by COVID-19 have just been 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 in 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. 180 participants with comparable baseline demographics and clinical characteristics to the ITT population were included in the subpopulation of patients without significant protocol deviations (PP sub-population).
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.
How is BPTS moving ahead?
In the first half of 2023, Biophytis (BPTS) plans to present the findings in-depth 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 well supported by these post-hoc evaluations. Additionally, BPTS intended to begin discussing these findings with regulatory bodies and health authorities in the upcoming months, notably in Europe, the US, and Brazil. The goal is to submit applications as soon as feasible in 2023 for conditional marketing authorization (Europe) and emergency use authorization (USA, Brazil).