Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS), a clinical-stage biotechnology company dedicated to developing therapeutics that combat the degenerative effects of aging, has submitted an application for Early Access Authorisation (EAA) in France to the French National Authority for Health (HAS).
The application is seeking approval for the use of Sarconeos (BIO101)[1] in the treatment of adult COVID-19 patients in a severe and potentially life-threatening form of the disease. There are currently no therapeutic alternatives suitable for this demographic, making Sarconeos a potentially groundbreaking solution.
Biophytis has submitted an EAA application to the HAS for their COVID-19 treatment, Sarconeos (BIO101), to be approved for early access in France. If successful, the programme could allow up to 6,000 patients with severe forms of the virus to be treated as early as Q4 2023.
The company has taken proactive steps to ensure that the drug is prepared for large-scale production and distribution with the use of external pharmaceutical subcontracting partners (CDMOs) and Intsel Chimos. A response regarding the application is expected by Q3 2023 at the latest.
Stanislas Veillet, CEO of Biophytis, proudly announced the positive outcome of the COVA study. The remarkable results showed a staggering 44% reduction in the risk of respiratory failure or early death.
Biophytis has since submitted an application to the early access program to expedite the availability of their Sarconeos (BIO101) to hospitalized individuals with severe forms of COVID-19. The application has been made with the support of their partner, Intsel Chimos.
Corinne Truffault, CEO of Intsel Chimos, expressed her delight and pride in supporting Biophytis in its pursuit for an EAA for Sarconeos (BIO101) for the treatment of severe Covid-19 cases. She further announced that her company is already making preparations to ensure a speedy distribution and availability of this treatment as soon as it is approved by the HAS.
ABOUT EARLY ACCESS
In France, early access to promising drug candidates has been made available through exceptional and exceptional measures. After the evaluation of their efficacy and safety by the National Agency for the Safety of Medicines and Health Products (ANSM), access to these unmet therapeutic needs has been granted by the HAS.
With this system, patients will have early access to effective remedies and treatments otherwise unavailable; this will provide them the opportunity to benefit from innovative medicinal products not yet authorised on the market.
Biophytis SA is an innovative clinical-stage biotechnology company dedicated to developing treatments that can slow down aging and improve functional outcomes for patients with age-related diseases, including severe respiratory failure due to COVID-19.
Our leading drug candidate, Sarconeos (BIO101), is a small-molecule therapy taken orally, currently in Phase 3 clinical trials in the US, Brazil, and Europe (SARA-31 and SARA-32). We are also trialling Sarconeos (BIO101) in a two-phase Phase 2-3 study (COVA) to treat severe respiratory complications of COVID-19 in Europe, Latin America, and the US.
Additionally, a pediatric formulation of Sarconeos (BIO101) is being developed for Duchenne Muscular Dystrophy (DMD). Based in Paris, France, and Cambridge, Massachusetts, Biophytis SA’s ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and its American Depositary Shares (ADSs) are listed on Nasdaq Capital Market (Ticker BPTS – ISIN: US09076G1040).