Positive final results from phase II- III COVA study of Sarconeos (BIO 101) in treatment of COVID-19-related respiratory failure.- Biophytis SA

Biophytis announces final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022. The final analysis demonstrates that COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with positive Post-Hoc analysis released on November 3, 2022.

Final COVA study results : The objective of the study was to investigate the efficacy and safety of Sarconeos (BIO 101), 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 of patients and time to respiratory failure or early death 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 (Intent To Treat, ITT population) were 63 years old on average, 64% of the patients were male, recruited in 37 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 (Per Protocol, PP sub-population) included 180 patients with similar baseline demographics and disease characteristics as the ITT population.The study met its pre-defined primary endpoint demonstrating a statistically significant difference between Sarconeos (BIO 101) and placebo in the proportion of patients with respiratory failure or early death at day 28, representing a relative reduction of risk of 44% (p=0.043, Cochran-Mantel-Haenszel test). Moreover, the analysis of time to respiratory failure or early death had shown significant differences over 28 days in the Kaplan Meier curves for Sarconeos (BIO 101) versus placebo (p=0.022). The pre-specified analysis of time to death over the complete follow-up period over 90 days showed that mortality rate with Sarconeos (BIO 101) was reduced compared to placebo in the ITT population (p=0.083) and in the PP population (p=0.038). Post hoc Kaplan-Meier analysis released on November 3, 2022 confirmed the effect of Sarconeos (BIO 101) on the primary endpoint and on mortality at day 90.

Sarconeos (BIO 101) has a very 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, mostly respiratory, adverse events (25% vs. 31%).

Biophytis is now initiating key regulatory activities to give access to Sarconeos (BIO 101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023. The strategy to give access to Sarconeos (BIO 101) as quickly as possible is to file for Early Access Programs (EAP) in France and Brazil, while filing for conditional Marketing Authorisation (CMA) in Europe and Emergency Use Authorization (EUA) in the USA.