Biophytis Shares Jump After Approval to give access to Sarconeos to Hospitalized COVID-19 Patients in Brazil

Feb 3, 2022 By MarketDepth

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Entrance to Hospital with bright lights

Biophytis SA (NASDAQ: BPTS) shares jumped more than 20% Thursday after the clinical-stage biotechnology company announced that it 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 patients who are mechanically ventilated in the Intensive Care Unit of Brazilian hospitals will be treated with Sarconeos (BIO101) for up to 28 days to prevent further deterioration and mortality.

“Making Sarconeos (BIO101) 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 (BIO101) as well as explore the potential effectiveness in mechanically ventilated patients, a novel potential indication.”

Stanislas Veillet, CEO of Biophytis

Whilst the number of hospitalized patients with severe COVID-19 is again steeply increasing, there are still very few options available for the treatment of severe Covid-19 disease, including when respiratory insufficiency is necessitating mechanical ventilation in the ICU. This EAP, giving access to Sarconeos (BIO101) to most severe cases of COVID-19 patients is complementing Biophytis effort to participate to the therapeutic armamentarium against COVID-19 along with the ongoing COVA Phase 2-3 study. The COVA study (the Principal Investigator in Brazil is Dr Ludhmila Hajjar, USP, InCor, Sao Paulo, Brazil), is evaluating Sarconeos (BIO101) for the treatment of severe respiratory manifestations of COVID-19 in non-intubated hospitalized patients.

“Brazil is now the third in the ranking of Covid-19 cases in the world and second in the number of deaths. Following the omicron surge, we are now facing again a steep increase in the number of cases which has led again to an increasing number of ICU admissions despite our advances in vaccination. Besides corticosteroids and the best standard of care, up to now, we have no options for patients on mechanical ventilation in which mortality rates remain at unacceptable levels. I am happy to collaborate in this new phase of application of this medicine that explores very innovative pathways in the treatment of severe cases and brings hope for better outcomes.”

Dr Suzana Lobo, head of the Intensive Care Division – Hospital de Base and FAMERP Medical School in S j Rio Preto- SP- Brazil, and EAP coordinating physician