Biophytis announces positive final results of the phase 2-3 COVA study with Sarconeos (BIO101) in severe COVID-19 - Seite 2

Biophytis is now initiating key regulatory activities to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023.  The strategy to give access to Sarconeos (BIO101) 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. An EAP has already been approved in 2022 in Brazil to treat COVID-19 patients at critical stage in Intensice Care Units (ICU) and the request to lift the hold given completion of the study and positive results is pending. The filing of the request for starting the EAP program in France is being prepared and will be made in Q1 2023 with the objective to be granted approval in Q2 2023. Requests for pre-submission meetings regarding conditional Marketing Authorisation in Europe and Emergency Use Authorization in the USA are under preparation and will be sent in Q1 2023, targeting an approval later in 2023, depending on feedback from authorities.

Biophytis will present the results in detail at the American Thoracic Society conference in Washington, DC, USA in May 2023 and at the European Respiratory Society Lung Science meeting in Estoril, Portugal, in March 2023.

Final COVA study results

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 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.