Benzinga -
- Biophytis SA (NASDAQ: BPTS) released the final results from its phase 2-3 COVA study evaluating Sarconeos (BIO101) for COVID-19-related respiratory failure.
- 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 in September 2022.
- The final analysis demonstrates that the COVA study met the primary endpoint, with a 44% statistically significant reduction in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with a positive Post-Hoc analysis released in November last year.
- An early access program was already approved in 2022 in Brazil to treat COVID-19 patients at a critical stage in Intensive Care Units. The request to lift the hold, given the completion of the study and positive results, is pending.
- The filing for the EAP program in France is being prepared and will be made in Q1 2023, expected to be approved in Q2 2023.
- Requests for pre-submission meetings regarding conditional Marketing Authorisation in Europe and Emergency Use Authorization in the U.S. are under preparation and will be sent in Q1 2023, targeting an approval later in 2023, depending on feedback from authorities.
- The data also showed that the mortality rate with Sarconeos (BIO101) was reduced compared to the placebo in the ITT and PP populations.
- Sarconeos (BIO101) was associated with a lower proportion of patients with adverse events compared to placebo (57% vs. 64%).
- Price Action: BPTS shares are up 95.10% at $0.80 during the premarket session on the last check Thursday.
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