Biophytis SA (NASDAQ:BPTS) shares hiked first thing Thursday, on word the company 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).
The company, with headquarters in Paris, France and Cambridge, Mass., said 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 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 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 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.
Said CEO Stanislas Veillet, "Making Sarconeos available to critically ill patients in the ICU with severe COVID-19 is planned to be the next step towards bringing our product to the market as quickly as possible.
"This program will generate important new information about the safety of Sarconeos as well as explore the potential effectiveness in mechanically ventilated patients, a novel potential indication."
BPTS shares are trading higher by 84 cents, or 18% at $5.48 early Thursday.
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