PARIS and CAMBRIDGE, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces the full results from the SARA-INT Phase 2 trial of Sarconeos (BIO101) in Sarcopenia that have been presented at the International Conference on Frailty and Sarcopenia Research (ICFSR) on September, 30th. ICFSR is the key international scientific event on Frailty and Sarcopenia and is attended by leading researchers, physicians and Biotech/Pharma in this field.
The results of SARA-INT, with safety and efficacy endpoints including subgroup analysis and secondary endpoints, have been presented by Cendrine Tourette, PhD Biophytis SARA Project Leader and discussed during a dedicated session, moderated by Waly Dioh PhD, Biophytis Chief Operations Officer and Roger A. Fielding, PhD, Principal Investigator of the SARA-INT trial, who heads the Nutrition, Exercise Physiology & Sarcopenia team at Tufts University in Boston.
Stanislas Veillet, CEO of Biophytis said: “Based on the good SARA-INT results, especially the significant effect of Sarconeos (BIO101) on the primary endpoint of the study in PP populations as well as in subpopulations of severe patients, Biophytis can now prepare the phase 3 study through interactions with regulatory agencies. We are committed to progress Sarconeos (BIO101) into phase 3 through partnerships. With the completion of Phase 2 and the preparation of Phase 3, Sarconeos (BIO101) remains the drug candidate with the potential to become the first drug approved for the treatment of Sarcopenia”.
Key highlights presented and discussed during the ICFSR are presented below:
Based on preliminary discussions with Key Opinion Leaders during the ICFSR conference, Biophytis is now preparing to start a phase 3 program in 2022 with Sarconeos (BIO101) at the highest dose (350 mg bid), targeting a population of sarcopenic patient at high risk of mobility disability similar to SARA-INT population, with similar endpoints, including the 400 MWT gait speed as primary end-point. The proposed program will be discussed with FDA and EMA, including during end-of-phase 2 meetings to be held later this year. Sarconeos (BIO101) has the potential to become the first drug to be approved for the treatment of Sarcopenia.
About BIOPHYTIS
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, being developed as a treatment for sarcopenia in a Phase 2 clinical trial in the United States and Europe (SARA-INT). It is also being 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
Disclaimer
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face" section from the Company's 2020 Annual Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.
Biophytis Contact for Investor Relations
Evelyne Nguyen, CFO
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Media contact
Life Sci Advisors
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Investor Relations
LifeSci Advisors, LLC
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