Biophytis has Filed with the French Countrywide Authority for Health (HAS) an Software for Early Access Authorisation (EAA) for Sarconeos (BIO101) in the Remedy of Intense Forms of COVID-19

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / May 26, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Progress Paris:ALBPS) (the “Organization” or “Biophytis”), a clinical-stage biotechnology firm focused on the development of therapeutics that slow the degenerative procedures affiliated with aging, such as intense respiratory failure in patients struggling from COVID-19, nowadays declared that it has submitted, by way of its pharmaceutical associate Intsel Chimos, an software for Early Accessibility Authorisation (EAA) in France with the French Nationwide Authority for Wellbeing (HAS) for the use of Sarconeos (BIO101)[1] in the treatment method of adult sufferers with a intense form of COVID-19, who are at risk of producing a critical form of the disease and for whom therapeutic options are not ideal.

Adhering to the optimistic effects of the COVA phase 2-3 analyze, Biophytis achieved with the HAS on March 9, 2023 for a pre-submission meeting to overview the eligibility necessities of the software. The Corporation is now pursuing this regulatory method by distributing the EAA application. If the software is accredited by the HAS, the early accessibility programme will allow for selected individuals with critical varieties of COVID-19 to be handled in France with Sarconeos (BIO101), whilst awaiting conditional Advertising and marketing Authorisation (MA) in Europe. Biophytis expects a response by Q3 2023 at the hottest, based on the delays taken by the HAS, and the initially people could be handled as early as Q4 2023.The industrial scale output of Sarconeos (BIO101) has been initiated with pharmaceutical subcontracting associates (CDMOs), in purchase to be able to address up to 6,000 sufferers if the EAA is accredited. Distribution will be managed by Intsel Chimos, with whom a partnership was signed in March 2023.

Stanislas Veillet, CEO of Biophytis, explained: “We have shown, by means of the favourable results of the COVA review, a statistically significant 44% reduction in the danger of respiratory failure or early demise. With the submission of our software for the early accessibility method, we as a result intend to speed up the availability in France of Sarconeos (BIO101) to hospitalized sufferers with significant types of COVID-19 by means of our husband or wife Intsel Chimos.”

Corinne Truffault, CEO of Intsel Chimos, stated: “We are delighted and incredibly happy to accompany Biophytis in this new regulatory phase to get hold of the EAA for Sarconeos (BIO101) in the treatment method of severe sorts of Covid-19. In parallel, we are getting ready to assure the distribution and availability of this remedy to sufferers in France as before long as the EAA is permitted by the HAS. “


Early accessibility in France is granted by the HAS immediately after the impression of the Countrywide Company for the Basic safety of Medications and Wellbeing Products and solutions (ANSM) on the presumed efficacy and security of the drug prospect. This is a process that will allow the early availability and fiscal protection, on an exceptional and derogatory basis, of particular medicinal items that satisfy an unmet therapeutic have to have, that are probable to be ground breaking, and that are not still authorised in a therapeutic indicator.


Biophytis SA is a clinical-stage biotechnology enterprise specialized in the improvement of therapeutics that are aimed at slowing the degenerative processes involved with growing older and strengthening purposeful outcomes for patients suffering from age-relevant illnesses, which includes significant respiratory failure in clients suffering from COVID-19. Sarconeos (BIO101), our primary drug prospect, is a compact molecule, administered orally, prepared to be produced as a remedy for sarcopenia in forthcoming Phase 3 medical trials in the United States, Brazil and Europe (SARA-31 and SARA-32). It has also been studied in a medical two-portion Stage 2-3 analyze (COVA) for the cure of extreme respiratory manifestations of COVID-19 in Europe, Latin The us, and the US. A pediatric formulation of Sarconeos (BIO101) is currently being designed for thetreatment of Duchenne Muscular Dystrophy (DMD). The Business is dependent in Paris, France, and Cambridge, Massachusetts. The Firm’s normal shares are shown on Euronext Development (Ticker: ALBPS -ISIN: FR0012816825) and ADSs (American Depositary Shares) are stated on Nasdaq Funds Marketplace (Ticker BPTS – ISIN: US09076G1040). For more info stop by


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[1] Sarconeos (BIO101) is the code name for Biophytis’ drug candidate. The active molecule is 20-hydroxyecdysone (20E)

Source: Biophytis

See supply edition on health-HAS-an-Application-for-Early-Accessibility-Authorisation-EAA-for-Sarconeos-BIO101-in-the-Remedy-of-Serious-Types-of-COVID-19