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Biophytis to Present Full Results From the SARA-INT Phase 2b Trial of Sarconeos (BIO101) in Sarcopenia at the 11th Annual International Conference on Frailty and Sarcopenia Research (ICFSR) September 29 – October 2, 2021

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Biophytis SA (NasdaqCM: BPTS) announced it will present full results from the SARA-INT Phase 2 trial of Sarconeos (BIO101) for sarcopenia at the International Congress on Frailty and Sarcopenia Research from September 29 to October 02, 2021. The results show a clinically meaningful improvement in the primary endpoint, the 400-meter walk test, with a good safety profile. Biophytis is now preparing for the Phase 3 program in response to these results, enhancing its potential in treating age-related diseases.

Positive
  • Clinically meaningful improvement in the 400-meter walk test (primary endpoint).
  • Good safety profile at doses of 175 mg bid and 350 mg bid.
  • Preparation for the Phase 3 program based on SARA-INT results.
Negative
  • None.

PARIS and CAMBRIDGE, Mass., Sept. 29, 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 it will present full results from the SARA-INT Phase 2 trial of Sarconeos (BIO101) in Sarcopenia at the International Congress on Frailty and Sarcopenia Research (ICFSR) to be held virtually from September 29 to October 02, 2021.

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 efficacy endpoints including subgroup analysis and secondary endpoints, will be presented by Cendrine Tourette PhD in a dedicated seminar on Thursday, September 30 at 9:00-9:30 AM EDT. The seminar will be followed by a Q&A session with Biophytis representatives: Cendrine Tourette, PhD (SARA Project Leader), Jean Mariani, MD, PhD (Board Director) and Waly Dioh, PhD (Chief Operating Officer). The Q&A session will be moderated by Roger A. Fielding, PhD, Principal Investigator of the SARA-INT trial and who heads the Nutrition, Exercise Physiology & Sarcopenia team at Tufts University in Boston.

Biophytis has previously announced the top-line results of the SARA-INT study. Data showed that Sarconeos (BIO101) at the highest dose (350 mg bid) demonstrated a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study. Sarconeos (BIO101) showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid. Based on the SARA-INT results, Biophytis is now preparing the phase 3 program and associated regulatory agency interactions.

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
evelyne.nguyen@biophytis.com

Media contact
Life Sci Advisors
Sophie Baumont
E: sophie@lifesciadvisors.com 
T: +33 6 27 74 74 49

Investor Relations
LifeSci Advisors, LLC
Ligia Vela-Reid
E: lvela-reid@lifesciadvisors.com 


FAQ

What were the results of the SARA-INT Phase 2 trial for Sarconeos (BPTS)?

The SARA-INT trial showed a clinically meaningful improvement in the primary endpoint, the 400-meter walk test.

What is the safety profile of Sarconeos (BPTS)?

Sarconeos (BIO101) demonstrated a very good safety profile at both 175 mg bid and 350 mg bid doses.

When will the results of the SARA-INT trial be presented?

The results will be presented at the International Congress on Frailty and Sarcopenia Research on September 30, 2021.

What are the next steps for Biophytis (BPTS) following the SARA-INT trial results?

Biophytis is preparing for the Phase 3 program and associated regulatory agency interactions.

What is the purpose of the SARA-INT trial for Sarconeos (BPTS)?

The SARA-INT trial aims to evaluate the efficacy and safety of Sarconeos (BIO101) in treating sarcopenia.

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