Biophytis SA (NASDAQ:BPTS) has received approval from the ANVISA (Brazilian health authority) for its Expanded Access Program (EAP) to treat hospitalized patients with severe COVID-19 with Sarconeos (BIO101).
- A maximum of 80 mechanically ventilated patients in the Intensive Care Unit of Brazilian hospitals will be treated with Sarconeos for up to 28 days to prevent further deterioration and mortality.
- This EAP, giving access to Sarconeos (BIO101) to most severe cases of COVID-19 patients, is complementing Biophytis' effort to participate in the therapeutic armamentarium against COVID-19 along with the ongoing COVA Phase 2-3 study.
- The COVA study is evaluating Sarconeos (BIO101) to treat severe respiratory manifestations of COVID-19 in non-intubated hospitalized patients.
- Brazil is the first country to approve the EAP to give access to Sarconeos (BIO101) to hospitalized COVID-19 patients.
- Based on this first approval and the upcoming completion of the COVA study during H1 2022, Biophytis is willing to extend the EAP submission to other countries.
- Price Action: BPTS shares are trading 14% at $5.30 during the premarket session on the last check Thursday.
