Biophytis Receives FDA IND Approval for Phase 2 Obesity Study

Paris (France) and Cambridge (Massachusetts, USA), July 11, 2024 – Biophytis SA announced it has received Investigational New Drug (IND) approval from the FDA for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The study’s primary goal is to measure muscle strength improvement in lower limbs using a knee extension test. Secondary endpoints include mobility analysis via a six-minute walk test and body composition assessment.

Marc-André Cornier, President-elect of the American Obesity Society and Professor of Medicine at the Medical University of South Carolina, will be the principal investigator. Cornier highlighted the importance of studying the safety and efficacy of new therapies in reducing muscle mass loss associated with incretin-based treatments.

The multicenter study will commence mid-2024 in the USA and could extend to Europe. Preliminary efficacy results are anticipated in 2025. Biophytis seeks funding and partnerships for the study. CEO Stanislas Veillet stated that obesity is a major medical challenge and believes that BIO101 could become a key treatment in preserving muscle mass and function in obese patients.