ANVISA (Brazilian Public Health Agency) has approved Biophytis’ Expanded Access Program (EAP) for hospitalized patients with severe COVID-19 who are on mechanical ventilation in the intensive care unit
Sarconeos (BIO101) treatment will be administered to a maximum of 80 mechanically ventilated patients in the intensive care units (ICUs) of Brazilian hospitals
In parallel, Sarconeos (BIO101) is being evaluated in a phase 2-3 study (COVA) in Europe, Latin America and the US for the treatment of non-intubated hospitalized patients with severe respiratory manifestations of COVID-19
PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / February 3, 2022 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS), (“Biophytis” or the “Company”), a clinical-stage biotechnology company based on the Sorbonne University campus focused on the development of therapeutics , which slow down associated degenerative processes with age, including severe respiratory failure in patients suffering from COVID-19, announces today that it has received approval from ANVISA (Brazilian Health Agency) for its Expanded Access Program (EAP) for treatment of hospitalized patients with severe COVID-19 using Sarconeos (BIO101). A maximum of 80 patients on mechanical ventilation in Brazilian hospital intensive care units will be treated with Sarconeos (BIO101) for up to 28 days to prevent further deterioration and mortality.
Stanislas Veillet, CEO of Biophytis, said: “The delivery of Sarconeos (BIO101) to critically ill patients in intensive care with severe Covid-19 is planned as the next step to bring our product to market as quickly as possible. This program will generate important new information on the safety of Sarconeos (BIO101) as well as investigate its potential efficacy in mechanically ventilated patients, a novel potential indication”.
As the number of hospitalized patients with severe COVID-19 surges again, there are still very few options available to treat severe COVID-19, even when respiratory failure requires mechanical ventilation in the ICU. This EAP, which provides access to Sarconeos (BIO101) for the most severe cases of COVID-19 patients, complements Biophytis’ efforts to join the COVID-19 therapeutic armory along with the ongoing COVA Phase 2-3 trial . The COVA study (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.
dr Suzana Lobo, Head of Intensive Care Unit – Hospital de Base and FAMERP Medical School in Sj Rio Preto – SP – Brazil, and EAP Coordinating Physician, said: “Brazil is now third in the ranking of Covid-19 cases in worldwide and on second in the number of deaths. Following the omicron surge, we are now faced with another steep increase in case numbers which, despite our progress on immunizations, has again resulted in increasing numbers of ICU admissions. Besides corticosteroids and the best standard of care, until now we have no options for patients on mechanical ventilation, where mortality rates remain at unacceptable levels. I am pleased to be collaborating in this new phase of the use of this drug, which is exploring very innovative ways in the treatment of severe cases and I hope to bring better results”.
The approval of an EAP by ANVISA is mainly based on the following criteria:
The product is intended for patients with severe debilitating and/or life-threatening illness.
There is no satisfactory therapeutic alternative with products approved in Brazil.
Authorization to use the product is given upon request and only under the responsibility of the prescribing physician as it is expected to bring significant benefit to the patient.
Brazil is the first country to approve the EAP to allow hospitalized COVID-19 patients access to Sarconeos (BIO101). Based on this initial approval and the upcoming completion of the COVA study in H1 2022, Biophytis is poised to expand the EAP filing to other areas of the world.
Biophytis SA is a clinical-stage biotechnology company focused on the development of therapeutics aimed at slowing down the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19.
Sarconeos (BIO101), our lead drug candidate, is an oral small molecule being developed for the treatment of sarcopenia, having completed a positive Phase 2 clinical trial in the United States and Europe (SARA-INT). It is also being evaluated in a two-part phase 2-3 clinical trial (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America and the United States. A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne muscular dystrophy (DMD).
The company is based in Paris, France and Cambridge, Massachusetts. The company’s common shares are listed on Euronext Growth (ticker: ALBPS – ISIN: FR0012816825) and its ADS (American Depositary Shares) are listed on Nasdaq (ticker BPTS – ISIN: US09076G1040).
For more information visit www.biophytis.com
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Biophytis contact person for investor relations
Evelyne Nguyen, Chief Financial Officer
Antoine Denry:[email protected]– +33 6 18 07 83 27
Agathe Boggio:[email protected]-+33 7 62 77 69 42
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