Biophytis S.A. announced the publication of an article on the results of its COVA phase 2-3 clinical trial in the treatment of respiratory symptoms in severe forms of COVID-19 in eClinicalMedicine, a medical journal part of the prestigious scientific review The Lancet. This publication is an endorsement of the strength of Biophytis' clinical research and the value of its drug candidate Sarconeos (BIO101) in the treatement of severe forms of COVID-19. Therapeutic advances are still needed in this pathology, as more than 230,000 patients will still have died of the virus worldwide in 2023, out of a total of nearly 7 million since the start of the pandemic.

As a reminder, the objective of the COVA Phase 2-3 study (ClinicalTrials.gov, NCT04472728) 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 and death. The proportion and time of onset of these adverse events were studied for 28 days, with mortality and safety monitored for more than 90 days. The main result was that in the study population (233 patients; 126 Sarconeos (BIO101) and 107 placebo), respiratory failure or early death by day 28, the primary end-point, was 11.4% lower in the Sarconeos (BIO101) (13.5%) than in the placebo (24.3%) group, (p = 0.0426).

Sarconeos (BIO101) significantly reduced the risk of death or respiratory failure by 44%, supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. To follow this publication, Biophytis will host two press conferences in France and the United States on 17 January 2024, alongside experts from the scientific and medical communities, to reiterate the potential and clinical benefits of Sarconeos (BIO101) in severe forms of COVID-19, and provide further details on the Group's strategic choice to explore the compound's potential in the treatment of other respiratory viral infections such as influenza.