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Biophytis (BPTSY) wins ANVISA approval for multi-regional BIO101 obesity trial

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Rhea-AI Filing Summary

Biophytis SA reports that Brazil’s health authority ANVISA has approved initiation of the Phase 2 OBA clinical trial of BIO101 in obesity, adding Brazil to previously secured approvals in the United States and Europe. This confirms the company’s capacity to run a multi-regional development program.

The OBA study will enroll 164 obese and overweight patients already treated with GLP-1 therapies to assess whether BIO101 can preserve muscle strength, mobility, and reduce sarcopenia risk. The primary endpoint is improvement in lower-limb strength measured by the knee extension test.

The trial is part of an existing licensing agreement with Brazilian partner Blanver, under which Biophytis may receive up to 108 million euros in upfront and milestone payments, plus double-digit royalties on future net sales in Latin America. EMBRAPII is providing non-dilutive financial support, and the study is scheduled to begin in early 2027.

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Phase of OBA trial Phase 2 Clinical development stage of the OBA obesity study for BIO101
Planned enrollment 164 patients Obese and overweight patients treated with GLP-1 in the OBA study
Blanver licensing potential 108 million euros Maximum upfront and milestone payments Biophytis may receive under the Blanver agreement
Study start timing early 2027 Scheduled start of the OBA Phase 2 clinical trial
Royalty level double-digit royalties Royalties on net sales of BIO101 in the licensed Latin American territory
GLP-1 receptor agonists medical
"driven by the high prevalence of the disease and the rapid development of GLP-1 receptor agonists"
GLP-1 receptor agonists are medicines that mimic a natural gut hormone to lower blood sugar and reduce appetite, often used to treat diabetes and obesity. Investors care because these drugs can drive large prescription sales, face strict regulatory approval and patent timelines, and their safety, pricing, or label changes can meaningfully affect a drug maker’s revenue much like a bestselling product or a recalled item would impact any company’s financial outlook.
sarcopenia medical
"position BIO101 for a second indication alongside its primary indication, which remains sarcopenia"
non-dilutive financial support financial
"the company is receiving non-dilutive financial support from EMBRAPII"
Phase 2 clinical trial medical
"The OBA study is a Phase 2 clinical trial evaluating BIO101 in 164 obese and overweight patients"
A phase 2 clinical trial is a research study that tests a new medical treatment or drug to see if it is effective and safe for a specific condition. It involves a larger group of people than earlier trials and helps determine whether the treatment should move forward to more extensive testing. For investors, successful phase 2 results can signal potential for future approval and commercial success, while setbacks may indicate challenges ahead.
licensing agreement financial
"This study is part of a licensing agreement with Blanver, one of the leading pharmaceutical companies"
A licensing agreement is a contract where one party gives another the right to use a product, technology, brand, patent or other protected asset in exchange for fees or royalties. For investors, it matters because such deals can provide steady revenue without the licensor bearing all the costs of production or distribution, change a company’s growth prospects, and alter risk depending on whether the rights are exclusive or limited — like renting out a tool instead of selling it outright.

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FAQ

What did Biophytis (BPTSY) announce regarding the OBA obesity trial in Brazil?
Biophytis announced that ANVISA approved the Phase 2 OBA trial of BIO101 in obesity in Brazil. This adds Brazil to existing approvals in the United States and Europe, enabling a multi-regional clinical program targeting mobility and muscle strength in obese patients on GLP-1 therapy.

What is the design of Biophytis (BPTSY) OBA Phase 2 obesity study?
The OBA study is a Phase 2 trial evaluating BIO101 in 164 obese and overweight patients treated with GLP-1 drugs. It will run in the US, Europe, and Brazil, with a primary objective of improving lower-limb muscle strength measured by the knee extension test.

How does BIO101 complement GLP-1 treatments according to Biophytis (BPTSY)?
Biophytis states that BIO101, when combined with GLP-1 therapies, could help preserve muscle strength, maintain mobility, and reduce sarcopenia risk in obese patients. GLP-1 drugs drive weight loss but are associated with reduced muscle mass and strength, creating a need for complementary treatments.

What financial terms does Biophytis (BPTSY) have with Blanver for BIO101 in obesity?
Under its licensing agreement with Blanver, Biophytis may receive up to 108 million euros in upfront and milestone payments. The company is also eligible for double-digit royalties on net sales in Latin American territories after future marketing authorizations are granted.

When is Biophytis (BPTSY) expecting to start the OBA obesity trial?
Biophytis indicates that the OBA Phase 2 trial of BIO101 in obese and overweight patients is scheduled to begin in early 2027. The study is supported by non-dilutive funding from EMBRAPII, a Brazilian public agency focused on clinical innovation.

What are Biophytis’ (BPTSY) main development indications for BIO101?
Biophytis describes BIO101 (20-hydroxyecdysone) as its lead candidate for muscular diseases and metabolic disorders. The primary indication is sarcopenia, with a Phase 3 program ready to start, and a second indication in obesity, with Phase 2 ready to start including the OBA trial.

 

 

 

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: August 10, 2026

 

Commission File Number: 001-38974

 

BIOPHYTIS S.A.

(Translation of registrant’s name into English)

 

 

Stanislas Veillet
Biophytis S.A.

Sorbonne University—BC 9, Bâtiment A 4ème étage

4 place Jussieu

75005 Paris, France

+33 1 44 27 23 00

(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 August 10, 2026, Biophytis S.A. issued a press release announcing the approval of the OBA clinical trial in Brazil and shares its outlook for BIO101 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 August 10, 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: August 10, 2026 By: /s/ Stanislas Veillet
    Name: Stanislas Veillet
    Title: Chairman and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

BIOPHYTIS ANNOUNCES APPROVAL OF THE OBA CLINICAL TRIAL IN BRAZIL AND SHARES ITS OUTLOOK FOR BIO101 IN OBESITY

 

Paris (France) and Cambridge (Massachusetts, U.S.), August 10, 2026, at 07:00am CET – Biophytis SA (Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a biotechnology company pioneering the development of transformative therapies for longevity, today announces that it has received approval from Brazil’s National Health Surveillance Agency (ANVISA) to begin the Phase 2 OBA clinical trial for obesity in Brazil and shares the outlook for its drug candidate BIO101 in obesity.

 

The authorization, published in the Diário Oficial da União (Brazil’s Federal Official Gazette), represents a key regulatory milestone for the study’s implementation in Brazil. It follows regulatory approvals already obtained in the United States and Europe, confirming Biophytis’ ability to conduct multi-regional clinical development in compliance with the requirements of major health authorities. Approval of the protocol enables Biophytis to proceed with the operational implementation of the OBA study in a strategic region characterized by a high prevalence of obesity and a growing unmet medical need.

 

Stanislas Veillet, Chairman and CEO of Biophytis, stated: “Obtaining this authorization from ANVISA, following those obtained in the United States and Europe, marks a pivotal milestone in the international rollout of our clinical trial for obesity. It thus strengthens our ability to execute an ambitious clinical strategy and address a new unmet medical need: improving mobility of obese patients in a rapidly expanding market. It will enable us to position BIO101 for a second indication alongside its primary indication, which remains sarcopenia, with the support of the Brazilian pharmaceutical company Blanver, which is responsible for developing BIO101 in the region”.

 

The global market for obesity treatments is experiencing very dynamic growth, driven by the high prevalence of the disease and the rapid development of GLP-1 receptor agonists (or “GLP-1”), which enable unprecedented weight loss and are driving a paradigm shift in the management of obesity. However, this weight loss is accompanied by a significant reduction in muscle mass and strength, and GLP-1 treatments alone do not improve mobility in patients with obesity.

 

It is in this context that Biophytis is developing BIO101, which, when used in combination with GLP-1-based therapies, could preserve muscle strength, restore mobility, and reduce the risk of sarcopenia in patients with obesity.

 

In the coming weeks, Biophytis will proceed to:

 

·The signing of a contract with Blanver, the partner pharmaceutical company, and EMBRAPII (Farmavax), the Brazilian public agency dedicated to promoting industrial innovation, for the clinical development project of BIO101 for obesity in Brazil. This contract, which follows the agreement reached last year, will enable the company to finalize preparations and launch the Phase 2 OBA trial at the primary investigator site, while ensuring its co-financing.

 

·The incorporation of a rebound effect study into its protocol by submitting an amendment to regulatory agencies (FDA, EMA, ANVISA), with the goal of testing BIO101’s effect on weight gain during the rebound phase. The risk of weight rebound upon discontinuation of GLP-1 therapy is a major risk and represents a very significant unmet medical need.

 

***

 

About the OBA Clinical Study

 

The OBA study is a Phase 2 clinical trial evaluating BIO101 in 164 obese and overweight patients treated with GLP-1 to explore its potential impact on muscle function and obesity-related complications. By combining BIO101 with GLP-1 therapy, this study aims to counteract the loss of muscle strength frequently observed during GLP-1-induced weight loss and to preserve mobility. Conducted in the US, Europe, and Brazil, the study’s primary objective is to measure improvements in lower-limb muscle strength, as assessed by the knee extension test.

 

 

 

 

 

This study is part of a licensing agreement with Blanver, one of the leading pharmaceutical companies in Brazil and Latin America, including but not limited to Brazil, Mexico, Argentina, and Colombia. Under the terms of this partnership, Biophytis may receive up to 108 million euros, including an upfront payment and subsequent milestone payments upon the achievement of certain objectives. Biophytis is also eligible to receive double-digit royalties on net sales in the relevant territory, following the granting of future marketing authorizations.

 

In addition, the company is receiving non-dilutive financial support from EMBRAPII, a Brazilian public agency dedicated to clinical innovation. The study is scheduled to begin in early 2027. Biophytis aims to generate robust clinical data in key regions of the global obesity market experiencing strong growth and remains underserved.

 

***

 

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.

 

 

Biophytis Contact

 

Investor relations

investors@biophytis.com

 

Media relations

Antoine Denry: antoine.denry@taddeo.fr – +33 6 18 07 83 27

Nizar Berrada: nizar.berrada@taddeo.fr – +33 6 38 31 90 50

 

 

 

Source: View Original Filing on SEC EDGAR

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