Announcement • Sep 12

Biophytis Evaluates BIO101’s Potential To Limit Weight Regain In OBA Clinical Study In Obesity

Biophytis SA 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. 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. 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. 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. 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 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 EUR 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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