Biophytis Obtains IND Approval from FDA for Phase 2 Obesity Study

Biophytis, a clinical-stage biotechnology company specializing in therapeutics for age-related diseases, has received Investigational New Drug (IND) approval from the FDA for its phase 2 OBA study in obesity with BIO101 (20-hydroxyecdysone).

The study aims to measure improvement in muscle strength in the lower limbs, mobility, and body composition. Marc-André Cornier, a noted expert in obesity, will lead the study. He emphasizes the importance of evaluating new therapies for reducing muscle mass loss and associated complications.

Set to commence mid-2024 in the USA with potential expansion to Europe, preliminary efficacy results are expected in 2025. Biophytis is seeking funding and partnerships to complete the study.

CEO Stanislas Veillet highlights the significant market opportunity in obesity treatment and the potential for BIO101 to become a reference treatment.