Biophytis obtains IND approval from the FDA to start its phase 2 OBA study in obesity

Biophytis announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone).

The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-André Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study.

Professor Marc-André Cornier commented: “I am very happy that the IND for the phase 2 OBA clinical study with BIO101 (20-hydroxyecdysone) has been approved by the FDA. It is critical for us to study the safety and efficacy of new therapies designed to reduce the risk of muscle mass loss and resulting muscle weakness with functional consequences that may be associated with incretin-based therapies. Additionally we might observe further weight loss over and above that obtainable with a GLP-1 RA.”

The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.

Stanislas Veillet, CEO de Biophytis, stated: “Obesity represents a major medical challenge and a significant growth opportunity for Biophytis. The obesity treatment market, estimated at $6 billion in 2023, is expected to reach $100 billion by 2030, with an average annual growth rate of 42%. Obtaining an IND from the FDA is a crucial step that will enable us to make rapid progress in this indication and attract new pharmaceutical partners. We are convinced that BIO101 could become a reference treatment for preserving muscle mass, strength and function in obese patients treated with GLP-1 RAs. This development has convinced our partner Blanver in Latin America, and we are convinced that it will attract new ones in other regions of the world where obesity is a major health issue.”