Biophytis Receives FDA IND Clearance for Phase 2 OBA Obesity Study

Biophytis SA, a clinical-stage biotechnology company based in Paris, France, and Cambridge, Massachusetts, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This approval allows the company to commence its phase 2 OBA clinical study targeting obesity with the drug candidate BIO101 (20-hydroxyecdysone). The study aims to evaluate the improvement in muscle strength, particularly in the lower limbs, through a knee extension test. Secondary objectives include assessing mobility using the 6-minute walk test and analyzing body composition to measure fat and lean mass.

The principal investigator for this study will be Professor Marc-André Cornier, a prominent figure in obesity research and President-elect of the American Obesity Society. With his extensive background as a Professor of Medicine and the Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, Cornier’s involvement lends significant credibility to the study.

Professor Cornier expressed his satisfaction with the FDA's approval of the IND application. He emphasized the importance of exploring new therapies that not only protect against muscle loss and weakness but also potentially enhance weight loss beyond what current GLP-1 receptor agonists (GLP-1 RAs) achieve.

The study, expected to start in mid-2024 in the USA, may also extend to Europe. Preliminary efficacy results for BIO101 (20-hydroxyecdysone) are anticipated in 2025. To support this ambitious project, Biophytis is actively seeking funding and partnerships.

Stanislas Veillet, CEO of Biophytis, highlighted the significant growth potential in the obesity treatment market, which was valued at $6 billion in 2023 and is expected to soar to $100 billion by 2030, growing at an average annual rate of 42%. Veillet underscored the importance of securing FDA approval as a key milestone that will facilitate rapid advancement in this area and attract new pharmaceutical partners. He expressed confidence that BIO101 could emerge as a benchmark treatment for maintaining muscle mass, strength, and function in obese patients undergoing treatment with GLP-1 RAs. Veillet also noted that this development has already garnered support from Blanver in Latin America and is likely to attract additional partnerships in other regions grappling with obesity.

Biophytis SA is dedicated to developing drug candidates to address age-related diseases. Their lead drug candidate, BIO101 (20-hydroxyecdysone), is being developed for various indications, including sarcopenia (phase 3 ready), Duchenne muscular dystrophy (phase 1-2 study to commence), respiratory conditions like COVID-19 (phase 2 completed), and metabolic diseases such as obesity (phase 2 about to begin). The company's ordinary shares are listed on Euronext Growth under the ticker ALBPS.