Biophytis updates obesity trial to track weight regain
Biophytis expands its phase 2 OBA obesity study to assess BIO101’s impact on post-semaglutide weight regain and muscle strength, targeting first patient enrollment in early 2027.
Rhea-AI Filing Summary
Biophytis SA (BPTSY) reported that it has submitted to Brazilian regulator ANVISA an amendment to the protocol of its phase 2 OBA clinical study in obesity. The amendment adds an evaluation of BIO101’s potential to limit weight regain after discontinuation of semaglutide, a GLP-1 receptor agonist. Submission of the same protocol to the U.S. FDA is expected in the coming days, with plans to start the study in the first quarter of 2027 and report results in the first half of 2028.
The OBA study will enroll 164 obese and overweight patients treated with semaglutide across the United States, Europe, and Brazil. The primary endpoint remains improvement in lower-limb muscle strength via knee extension test, while the amended protocol adds a 12-week follow-up after a 21-week semaglutide treatment period to characterize weight regain and assess BIO101’s role in maintaining benefits. The study is conducted under a licensing agreement with Blanver, under which Biophytis may receive up to €108 million in upfront and milestone payments plus double-digit royalties, and also benefits from non-dilutive support from EMBRAPII.
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Filing Explained
The amendment to the OBA study has been submitted to ANVISA but is not reported as approved; the FDA submission is still expected. ANVISA and FDA responses are estimated at 90 and 30 days, respectively, so the added 12-week weight-regain assessment remains subject to regulatory review and the planned study start.
Key Figures
Key Terms
GLP-1 receptor agonist medical
rebound effect medical
phase 2 clinical trial medical
knee extension test medical
licensing agreement financial
double-digit royalties financial
FAQ
What did Biophytis (BPTSY) announce regarding the OBA obesity study?
How many patients will be included in Biophytis’ OBA phase 2 trial?
What new evaluation period is added to the Biophytis OBA study protocol?
When does Biophytis plan to start and report results from the OBA study?
What are the potential financial terms of Biophytis’ agreement with Blanver?
What regulatory timelines did Biophytis outline for the OBA protocol amendment?
What is the primary endpoint of Biophytis’ OBA phase 2 trial?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of report: September 9, 2026
Commission File Number: 001-38974
BIOPHYTIS S.A.
(Translation of registrant’s name into English)
Stanislas Veillet
Biophytis S.A.
Silver Innov
54 rue Molière
94200 Ivry sur Seine, France
+33 1 76 28 40 83
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
x Form 20-F ¨ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
On September 9, 2026, Biophytis S.A. issued a press release announcing that it has submitted to the Brazilian Health Regulatory Agency (ANVISA) an amendment to the protocol of the phase 2 OBA clinical study in obesity. A copy of the press release is attached as Exhibit 99.1 to this Form 6-K.
EXHIBIT LIST
| Exhibit | Description | |
| 99.1 | Press Release dated September 9, 2026. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BIOPHYTIS S.A. | ||
| Date: September 9, 2026 | By: | /s/ Stanislas Veillet |
| Name: Stanislas Veillet | ||
| Title: Chairman and Chief Executive Officer | ||
Exhibit 99.1
Biophytis to evaluate BIO101’s potential to limit weight regain in its OBA clinical study in obesity
| · | Regulatory protocol amendment filed in Brazil, with submissions planned in the United States and Europe |
| · | “Rebound effect”: expansion of the scope of BIO101 evaluation following semaglutide discontinuation |
| · | A new follow-up phase to assess weight regain and the role of BIO101 |
Paris (France) and Cambridge (Massachusetts, U.S.), September 9, 2026, at 07:00am CET – Biophytis SA (Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a pioneering company in the development of transformative therapies impacting longevity, today announces that it has submitted to the Brazilian Health Regulatory Agency (ANVISA) an amendment to the protocol of the phase 2 OBA clinical study in obesity.
This protocol amendment includes the evaluation of BIO101's potential to limit weight regain, or "rebound effect," observed after discontinuation of treatment with semaglutide, a GLP-1 receptor agonist. Submission of the same amendment to the U.S. Food and Drug Administration (FDA) is expected in the coming days.
This new evaluation complements the initial objective of the OBA study, which is to measure the effect of BIO101 on muscle function and mobility in obese or overweight patients treated with a GLP-1 agonist. In particular, the study aims to determine whether BIO101 can preserve lower-limb muscle strength during semaglutide-induced weight loss.
A new dimension in the evaluation of BIO101
The amended protocol provides for the evaluation of the rebound effect under BIO101 following discontinuation of the 21-week semaglutide treatment. While GLP-1 receptor agonist–based treatments enable significant weight loss, their discontinuation may be followed by weight regain. The addition of an evaluation period therefore addresses an important clinical issue for patients treated with semaglutide.
The follow-up period added to the OBA study protocol, which follows semaglutide treatment, extends over 12 weeks: it will make it possible to characterize any weight regain and to explore the role of BIO101 in maintaining the benefits achieved during the semaglutide treatment phase. Preventing or reducing this rebound effect represents a new therapeutic opportunity for BIO101, complementing its potential in preserving muscle mass, strength, and mobility.
Stanislas Veillet, Chairman and Chief Executive Officer of Biophytis, stated: " The submission of this amendment to ANVISA marks an important new step in the development of BIO101 in obesity. Evaluating the period following semaglutide discontinuation will allow us to explore a major clinical issue: weight regain after discontinuation of treatment with a GLP-1 receptor agonist. With this new dimension, the OBA study could provide data on the potential of BIO101 both during weight loss and during the rebound period. We plan to submit the same protocol to the FDA in the coming days, followed by the EMA, with the goal of starting the study in the first quarter of 2027 and reporting in the first half 2028."
Biophytis expects to receive a response from ANVISA within an estimated regulatory timeframe of 90 days. The expected response time from the FDA is 30 days, subject to any additional requests from the authorities.
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In the coming weeks, Biophytis will carry out the regulatory and operational steps necessary for the international deployment of the OBA study:
| · | Submission of the protocol amendment to the FDA and to the European Medicines Agency (EMA) in the coming weeks; |
| · | Finalization of agreements with Blanver, the pharmaceutical partner, and EMBRAPII (Farmavax), the Brazilian public agency dedicated to promoting industrial innovation, for the clinical development of BIO101 in obesity in Brazil. |
| · | Study start, with the first patient enrolled ("First Patient First Visit"), expected in the first quarter of 2027. |
About the OBA Clinical Study
The OBA study is a phase 2 clinical trial evaluating BIO101 in 164 obese and overweight patients treated with semaglutide. Conducted in the United States, Europe, and Brazil, it aims to explore the potential of BIO101 on muscle function, mobility, and certain complications associated with obesity.The study's primary endpoint is the improvement in lower-limb muscle strength, assessed by the knee extension test. The amended protocol also provides for an evaluation of weight regain beyond the 21 weeks of semaglutide treatment, over an additional 12-week period.
By combining BIO101 with GLP-1 treatment, Biophytis aims to explore an approach designed to preserve muscle strength and mobility during weight loss, while also evaluating BIO101's potential to limit weight regain after semaglutide discontinuation. The study is part of the licensing agreement entered into with Blanver, one of the leading pharmaceutical companies in Brazil and Latin America, with a presence notably in Brazil, Mexico, Argentina, and Colombia. Under the terms of this partnership, Biophytis could receive up to €108 million, including an upfront payment and additional payments contingent on the achievement of certain milestones. Biophytis is also eligible to receive double-digit royalties on net sales in the relevant territory, following the receipt of future marketing authorizations. Biophytis further benefits from non-dilutive financial support from EMBRAPII, the Brazilian public agency dedicated to industrial innovation.
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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 metabolic disorders (obesity, Phase 2 ready to start). 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 because of new information or otherwise, except as required by law.
Biophytis Contacts
Investor Relations
Investors@biophytis.com
Media contacts
Antoine Denry: antoine.denry@taddeo.fr – +33 6 18 07 83 27
Nizar Berrada : nizar.berrada@taddeo.fr – +33 6 38 31 90 50
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