Clinical-stage biotechnology company Biophytis SA (Euronext Growth Paris:ALBPS) (OTC:BPTSY) announced on Monday that it has received approval from Brazil's National Health Surveillance Agency (ANVISA) to begin its Phase 2 OBA clinical trial evaluating BIO101 in obesity.

This authorisation marks a regulatory milestone for the study in Brazil and follows approvals previously obtained in the United States and Europe, supporting Biophytis' multi-regional clinical development strategy.

The OBA trial will evaluate BIO101 in combination with GLP-1 therapies in 164 obese and overweight patients, focusing on muscle function and obesity-related complications. The study's primary objective is to assess improvements in lower-limb muscle strength through the knee extension test.

Biophytis is developing BIO101 as a potential complement to GLP-1 therapies, with the aim of preserving muscle strength, restoring mobility and reducing the risk of sarcopenia associated with GLP-1-induced weight loss.

In the coming weeks, the company expects to sign agreements with pharmaceutical partner Blanver and Brazilian public innovation agency EMBRAPII (Farmavax) to support the clinical development and co-financing of the trial in Brazil. Biophytis also plans to submit protocol amendments to the FDA, EMA and ANVISA to study BIO101's potential effect on weight gain during the rebound phase following GLP-1 treatment discontinuation.

The OBA study is being conducted in the United States, Europe and Brazil and is scheduled to begin in early 2027.

Under its licensing agreement with Blanver, Biophytis may receive up to EUR108m in upfront and milestone payments and is eligible for double-digit royalties on net sales in the relevant territory following future marketing authorisations. Biophytis also receives non-dilutive financial support from EMBRAPII.

The company aims to generate clinical data in key, rapidly growing obesity markets.