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Biophytis S.A.
Regulatory Filings • Mar 17, 2025
1153_iss_2025-03-17_d683f767-24b7-4051-b125-bee0c4ab1bb8.pdf
Regulatory Filings
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Press release
Biophytis revolutionizes sarcopenia
- publication of SARA-INT Phase II results for BIO101
- confirmation of Phase 3 readiness
Paris (France), Cambridge (Massachusetts, USA), March 17, 2025 – 07.00 AM CET – Biophytis SA (Euronext Growth Paris : ALBPS), ("Biophytis" or the "company"), a clinical-stage biotechnology company specialized in developing therapies for age-related diseases, is excited to announce a world premiere: the publication of the Phase 2 clinical trial SARA-INT in the Journal of Cachexia, Sarcopenia and Muscle (JCSM), the key reference journal for research on sarcopenia.
Key BIO101 Attributes from the SARA INT Trail include:
- Promising Efficacy: BIO101 350mg bid demonstrates a clinically meaningful improvement in the 400-meter walk test (400MWT), primary endpoint of the study
- Excellent Safety: At all doses, BIO101 shows a very good safety profile with no Serious Adverse Events (AE) related to the product
- Greater Efficacy in high-risk population: Nominally significant treatment effect versus placebo in the 400MWT gait speed in slow walkers and sarcopenic obesity subpopulations
Complete publication can be found here
Biophytis has made significant progress in obtaining regulatory approvals for its Phase 3 trial in sarcopenia and is accelerating discussions with a major international pharmaceutical company in China as well as other industrial partners in Asia.
Key features to remind:
- Ø Sarcopenia affects between 121 and 194 million people worldwide, a trend that will further accelerate in the coming years and decades with the aging of the population
- Ø No therapeutic solution exists today for treating sarcopenia
- Ø Biophytis is the most advanced company in this indication with BIO101
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About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for agerelated diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company's ordinary shares are listed on Euronext Growth
Press release
Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). 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 2023 Financial 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.
Contact Biophytis
Investor relations [email protected]
US Investors Pascal Nigen – Alpha Bronze [email protected]
Media contacts
Antoine Denry : [email protected] – +33 6 18 07 83 27 Inès de Mandiargues : [email protected] - +33 6 16 16 51 78