PARIS, FRANCE and CAMBRIDGE, MASSACHUSETTS / ACCESSWIRE / June 27, 2022 / Biophytis SA (NASDAQ: BPTS)(Euronext Growth Paris: ALBPS)(“Biophytis” or the “Company”), a clinical-stage biotechnology company focused on developing therapies that slow the degenerative processes associated with aging and improve functional outcomes in patients with age-related diseases, has announced today that she is giving an oral presentation on the development of Sarconeos (BIO101) for the treatment of sarcopenia at the 15th SCWD (Society on Sarcopenia, Cachexia & Wasting Disorders) International Congress.
This oral presentation given by Drs. Waly Dioh and Cendrine Tourette and entitled: “BIO101 in development for the treatment of Sarcopenia” summarizes the major milestones in the development of Sarconeos (BIO101) already completed, mainly the results of the Phase 2 SARA-INT study as well as the major lines of the SARA Phase 3 study that the Company intends to initiate before the end of 2022.
Based on the results of the SARA-INT Phase 2 study, the company sought the scientific opinion of the European (EMA) and American (FDA) regulatory authorities in order to define the design and start-up conditions of the SARA Phase program. 3. Sarconeos (BIO101) has the potential to be the first drug candidate to enter phase 3 in sarcopenia.
The recent publication of the first results of the European SPRINTT study, a pan-European clinical study in elderly patients with sarcopenia, has provided new data which supports the design of a phase 3 study in this indication. The SPRINTT study showed, confirming the previous LIFE study in the United States, that the risk of motor disability in patients with severe sarcopenia can be estimated by measuring over a period of 1 to 3 years the loss of ability to walk 400m
The Sarconeos Phase 3 study (BIO101) will target 600 to 900 patients over the age of 65 with severe sarcopenia (3 ≤ SPPB ≤ 7), low walking speed (4m) ≤ 0.8 m/s and low grip strength (HGS
Patients will be treated for at least 12 months receiving either placebo or 350 mg of Sarconeos (BIO101) bid
The primary endpoint will be the ability to complete the 400m walk test in less than 15 minutes, and the following secondary endpoints will be used: walking speed at 4m from SPPB, hand grip strength (HGS) and patient reported outcome (PRO).
The duration of this study is estimated at 36 months from the inclusion of the first patient scheduled for the end of 2022.
However, the design of this study may change depending on ongoing discussions with European and American health authorities. The company intends to file a clinical trial application (CTA) in Q4 2022, depending on final discussions with the FDA and EMA.
Stanislas Veillet, CEO of Biophytis, says: “Sarcopenia has only very recently been recognized as a disease that can be diagnosed without an effective treatment option despite the enormous medical need. The recent publication of the first results of the European SPRINTT study, together with the results of the LIFE study in the United States, now provide sufficient supporting data to initiate a phase 3 program for the first time in patients with sarcopenia. We are currently in discussions with European and US health authorities to finalize the SARA 3 phase design and hope that we can move forward with the clinical trial application before the end of the year. is currently approved for sarcopenia globally, we are pioneers in this field and intend to continue to establish our leadership position by being the first company to launch a Phase 3 program.”
Biophytis SA is a clinical-stage biotechnology company specializing in the development of therapeutics aimed at slowing the degenerative processes associated with aging, including severe respiratory failure in patients with COVID-19. Sarconeos (BIO101), our lead drug candidate, is a small molecule, orally administered, has just reached its phase 2 development in the treatment of sarcopenia in the United States and Europe (SARA-INT). It is also being studied in a two-part Phase 2-3 (COVA) clinical study 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 ordinary shares are listed on Euronext Growth (Ticker: ALBPS – ISIN: FR0012816825) and the ADS (American Depositary Shares) are listed on Nasdaq (Ticker BPTS – ISIN: US09076G1040).
For more information, visit www.biophytis.com
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Contact Biophytis for Investor Relations
Philippe Rousseau, Chief Financial Officer
THE SOURCE: Biophytis
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https://www.accesswire.com/706695/Biophytis-Presents-the-Development-of-Sarconeos-BIO101-in-Phase-3-for-the-Treatment-of-Sarcopenia-at-the-15th-SCWD- International Congress