Biophytis Unveils Phase 2 OBA Clinical Study Design in Obesity

Biophytis SA, a biotechnology company focusing on age-related diseases, has announced the protocol for its upcoming phase 2 OBA clinical trial, which will assess the effect of BIO101 (20-hydroxyecdysone) on obesity. The study aims to explore this treatment in obese and overweight patients who are beginning therapy with GLP-1 RAs.

CEO Stanislas Veillet highlighted the importance of addressing obesity, noting the significant market potential and expressing confidence in BIO101's capabilities in maintaining muscle function during weight loss treatments. The trial, slated to begin in mid-2024 pending regulatory approval, will include 164 patients who will undergo a double-blind, placebo-controlled test over 21 weeks.

Efficacy will be primarily gauged through muscle strength measurements, with secondary outcomes involving various physical and muscle mass assessments, biomarkers, and Patient-Reported Outcomes (PROs). Additionally, Biophytis is preparing to file an Investigational New Drug (IND) application in the U.S. to commence the study.

The company expects initial results from the trial, which focuses on the safety and efficacy of BIO101, by 2025. This aligns with their broader commitment to developing therapeutics for complex age-related conditions.