Biophytis: Amendment Filed to Extend OBA Study
The Parisian biotech company has submitted an amendment to regulatory authorities aimed at expanding the scope of its phase 2 OBA study in obesity. Beyond preserving muscle function, it adds the evaluation of weight regain following the discontinuation of semaglutide, a GLP-1 receptor agonist. This direction is part of the development of BIO101, the group's lead drug candidate.
Protocol Amendment Submitted in Brazil, Then in the United States and Europe
Biophytis announced on September 9, 2026 that it had submitted to the Brazilian regulatory agency (ANVISA) an amendment to the protocol of the phase 2 clinical study OBA in obesity. This amendment provides for evaluating the potential of BIO101 to limit weight regain, or rebound effect, observed after discontinuation of semaglutide treatment. The same submission to the Food and Drug Administration (FDA) is expected in the coming days, followed by submission to the European Medicines Agency (EMA) in the coming weeks. The company indicates it is banking on a regulatory timeframe estimated at 90 days for ANVISA's response, and 30 days for the FDA's response, subject to additional requests from the authorities.
12-Week Follow-Up After Semaglutide Discontinuation
The OBA study initially aims 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 preservation of lower limb muscle strength during weight loss induced by semaglutide. The amended protocol adds a 12-week follow-up period after the 21 weeks of semaglutide treatment, intended to characterize any weight regain and explore the role of BIO101. Conducted in the United States, Europe, and Brazil, the study involves 164 obese or overweight patients treated with semaglutide. According to Stanislas Veillet, Chief Executive Officer, the submission of this amendment marks a new milestone in the development of BIO101 in obesity, with the objective of launching the study in the first quarter of 2027 and publishing results in the first half of 2028. The study is part of a licensing agreement concluded with Blanver, under which Biophytis could receive up to 108 million euros, including an upfront payment and payments contingent upon achieving certain milestones.
