Biophytis Revolutionizes Sarcopenia
Rhea-AI Summary
Biophytis (FP: ALBPS) has announced the publication of its Phase 2 clinical trial SARA-INT results for BIO101 in the Journal of Cachexia, Sarcopenia and Muscle. The trial demonstrated promising efficacy for treating sarcopenia, showing clinically meaningful improvement in the 400-meter walk test at 350mg bid dosing.
Key findings include:
- Excellent safety profile with no serious adverse events
- Significant treatment effects versus placebo in slow walkers and sarcopenic obesity subpopulations
- Progress in obtaining Phase 3 trial regulatory approvals
The company is advancing discussions with a major pharmaceutical company in China and other Asian partners. Notably, sarcopenia affects 121-194 million people globally, with no current therapeutic solutions available. Biophytis positions itself as the most advanced company developing treatment for this age-related condition.
Positive
- Successful Phase 2 trial results with clinically meaningful improvement in primary endpoint
- Excellent safety profile with no serious adverse events
- Publication in prestigious Journal of Cachexia, Sarcopenia and Muscle
- Large market potential with 121-194 million affected patients globally
- First-mover advantage in sarcopenia treatment development
- Advanced discussions with major pharmaceutical partners in Asia
Negative
- Product still requires Phase 3 trial completion and regulatory approval
- Partnership discussions still ongoing without confirmed agreements
Publication of SARA-INT Phase II results for BIO101
Confirmation of Phase 3 readiness
Paris, France and Cambridge, Massachusetts--(Newsfile Corp. - March 17, 2025) - Biophytis SA (FP: 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:
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
No therapeutic solution exists today for treating sarcopenia
Biophytis is the most advanced company in this indication with BIO101
***
About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age- related 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 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
Investors@biophytis.com
US Investors
Pascal Nigen - Alpha Bronze
pnigen@alphabronzellc.com
Media contacts
Antoine Denry : antoine.denry@taddeo.fr - +33 6 18 07 83 27
Inès de Mandiargues : ines.demandiargues@taddeo.fr - +33 6 16 16 51 78
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/244757
FAQ
What were the key results of Biophytis' SARA-INT Phase 2 trial for BIO101?
How many people are affected by sarcopenia globally?
What are Biophytis' next steps for BIO101 development?
Are there any current therapeutic treatments available for sarcopenia?
