Biophytis, US09076G104026.05.2023 - 08:03:16
Biophytis has filed with the French National Authority for Health an application for Early Access Authorisation for Sarconeos in the treatment of severe forms of COVID-1
Following the positive results of the COVA phase 2-3 study, Biophytis met with the HAS on March 9, 2023 for a pre-submission meeting to review the eligibility requirements of the application. The Company is now pursuing this regulatory process by submitting the EAA application. If the application is approved by the HAS, the early access programme will allow certain patients with severe forms of COVID-19 to be treated in France with Sarconeos (BIO101), while awaiting conditional Marketing Authorisation (MA) in Europe. Biophytis expects a response by Q3 2023 at the latest, depending on the delays taken by the HAS, and the first patients could be treated as early as Q4 2023.? The industrial scale production of Sarconeos (BIO101) has been initiated with pharmaceutical subcontracting partners (CDMOs), in order to be able to treat up to 6,000 patients if the EAA is approved. Distribution will be handled by Intsel Chimos, with whom a partnership was signed in March 2023.
Stanislas Veillet, CEO of Biophytis, said: "We have demonstrated, through the positive results of the COVA study, a statistically significant 44% reduction in the risk of respiratory failure or early death. With the submission of our application for the early access program, we therefore intend to accelerate the availability in France of Sarconeos (BIO101) to hospitalized patients with severe forms of COVID-19 via our partner Intsel Chimos.?
Corinne Truffault, CEO of Intsel Chimos, said: "We are delighted and very proud to accompany Biophytis in this new regulatory step to obtain the EAA for Sarconeos (BIO101) in the treatment of severe forms of Covid-19. In parallel, we are preparing to ensure the distribution and availability of this treatment to patients in France as soon as the EAA is approved by the HAS. ?
ABOUT EARLY ACCESS?
Early access in France is granted by the HAS after the opinion of the National Agency for the Safety of Medicines and Health Products (ANSM) on the presumed efficacy and safety of the drug candidate. This is a system that allows the early availability and financial coverage, on an exceptional and derogatory basis, of certain medicinal products that meet an unmet therapeutic need, that are likely to be innovative, and that are not yet authorised in a therapeutic indication.
Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, planned to be developed as a treatment for sarcopenia in upcoming Phase 3 clinical trials in the United States, Brazil and Europe (SARA-31 and SARA-32). It has also been studied in a clinical two-part Phase 2-3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America, and the US. 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 ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and ADSs (American Depositary Shares) are listed on Nasdaq Capital Market (Ticker BPTS ? ISIN: US09076G1040). For more information visit www.biophytis.com
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 Sarconeos (BIO101) is the code name for Biophytis' drug candidate. The active molecule is 20-hydroxyecdysone (20E)
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