Biophytis Submits IND Application to US FDA for Phase 2 Obesity Study

Biophytis SA, a clinical-stage biotechnology firm based in Paris and Cambridge, Massachusetts, has taken a significant step in its research and development efforts by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The application pertains to its phase 2 OBA clinical study, which aims to evaluate the efficacy and safety of BIO101 (20-hydroxyecdysone) in treating obesity and overweight patients with secondary comorbidities.

The OBA study focuses on patients undergoing 21 weeks of treatment with GLP-1 receptor agonists (GLP-1 RAs) while adhering to a hypocaloric diet. The main goal is to measure improvements in muscle strength of the lower limbs, specifically through knee extension tests. Additionally, the study will investigate several secondary endpoints, including mobility assessed by the 6-minute walk test and changes in body composition, such as fat mass and lean body mass.

This placebo-controlled, multicenter international study is slated to begin in mid-2024, pending regulatory approval from the FDA, which is anticipated no sooner than 30 days following the application submission. The initial patient treatments are expected to commence in the latter half of 2024. Biophytis is also working to expand its research capabilities by incorporating European clinical centers into the study.

The results from the OBA study are expected to be available in 2025. The study will be overseen by Professor Marc-André Cornier, a globally recognized expert in obesity and the President-Elect of the US-based Obesity Society. Professor Cornier, who has joined Biophytis' Scientific Advisory Board for the OBA project, brings extensive experience in the field and currently serves as the Director of the Division of Endocrinology, Diabetes, and Metabolic Diseases at the Medical University of South Carolina. He is supported by other board members, including Professor Dennis Villareal and Professor Francisco Guarner.

Stanislas Veillet, CEO of Biophytis, emphasized the importance of this research by highlighting the substantial market potential. With an estimated 15 million adults in the US expected to be treated with anti-obesity medications by 2030, representing a market of $100 billion, Biophytis aims to position itself strategically within this domain. Veillet noted that the IND application submission demonstrates the company's commitment to advancing its development in obesity treatment, making it an attractive prospect for potential pharmaceutical partners.

Professor Cornier's extensive background includes serving on the faculty at the University of Colorado, where he held significant roles such as the Associated Division Head for Endocrinology and the Medical Director of the University of Colorado Anschutz Health and Wellness Center. From 1999 to 2016, he was a clinical endocrinologist at Denver Health Medical Center and later at Aspen Valley Hospital until 2021.

An active clinical and translational researcher, Dr. Cornier focuses on understanding the intricate regulation of food intake and body weight, alongside researching effective interventions for weight management and metabolic health. He has been involved in clinical trials exploring investigational treatments for lipid disorders and obesity. Dr. Cornier's dedication extends to active participation in several health-related organizations, including the Endocrine Society, American Diabetes Association, American Heart Association, National Lipid Association, and The Obesity Society.

Biophytis is committed to developing therapeutic solutions for age-related diseases, with BIO101 (20-hydroxyecdysone) as its leading drug candidate. The company is focused on addressing various conditions, including sarcopenia, Duchenne muscular dystrophy, COVID-19 related respiratory issues, and metabolic diseases such as obesity. 

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