Clinical-stage biotechnology company Biophytis SA (Euronext Growth Paris:ALBPS) (OTC:BPTSY) announced on Wednesday that it has filed a protocol amendment in Brazil for its Phase 2 OBA clinical study to evaluate BIO101's potential to limit weight regain following semaglutide discontinuation, with submissions also planned in the United States and Europe.

The amended protocol adds a 12-week follow-up after the initial 21-week semaglutide treatment to characterise weight regain and assess whether BIO101 can help maintain benefits achieved during treatment.

This expansion complements the study's original objective of evaluating BIO101's effect on muscle function and mobility in 164 obese and overweight patients receiving a GLP-1 agonist, including its potential to preserve lower-limb muscle strength during semaglutide-induced weight loss.

Biophytis expects a response from the Brazilian Health Regulatory Agency (ANVISA) within about 90 days and from the US Food and Drug Administration (FDA) within 30 days, subject to additional regulatory requests.

The company plans to submit the amendment to the FDA and European Medicines Agency in the coming weeks and finalise agreements with pharmaceutical partner Blanver and Brazilian innovation agency EMBRAPII.

Enrolment of the first patient is expected in the first quarter of 2027.

Under its licensing agreement with Blanver, Biophytis could receive up to EUR108m, including upfront and milestone payments, as well as double-digit royalties on net sales in the relevant territory following future marketing authorisations.