The multi-centre study is planned to take place in the US. Credit: Hunterframe / Shutterstock.

Biophytis has obtained investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to initiate its Phase II OBA clinical study.

The study will assess the efficacy of BIO101 (20-hydroxyecdysone) in treating obesity, focusing on muscle strength improvement in the lower limbs. 

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The trial’s primary endpoint is to evaluate the enhancement of muscle strength through a knee extension test.  

Secondary objectives include the assessment of mobility, determined by the six-minute walk test, and body composition, which will measure fat and lean mass.  

American Obesity Society president-elect and obesity expert Marc-André Cornier will oversee the study as the principal investigator. 

Scheduled to begin in mid-2024, the multi-centre study will take place in the US, with potential expansion to European sites. 

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Biophytis anticipates preliminary results on BIO101’s efficacy by 2025. The company is actively seeking financial support and strategic partnerships to facilitate the completion of this pivotal study. 

Biophytis CEO Stanislas Veillet said: “The obesity treatment market, estimated at $6bn in 2023, is expected to reach $100bn 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.” 

In July 2023, Biophytis filed for approval from the FDA to launch SARA-31, which will be the first Phase III study in sarcopenia.