Biophytis Initiates Phase 2 Obesity Trial with BIO101

Biophytis SA announced the initiation of a new clinical development program named OBA. This program will explore the potential use of BIO101 (20-hydroxyecdysone) in combination with GLP-1 receptor agonists for treating obesity. Biophytis focuses on creating therapeutics targeting age-related diseases.

Obesity treatments often lead to muscle mass loss, particularly when combined with GLP-1 receptor agonists. These drugs are effective in achieving weight loss, but one downside is that a significant portion of this weight loss—up to 40%—comes from muscle tissue. This muscle loss raises concerns as muscle tissue is crucial for both motor function and metabolic regulation.

The potential market for anti-obesity medications in the U.S. is substantial. By 2030, it is anticipated that over 15 million adults, or 13% of the adult population, will be using such treatments. The market size was projected to be $6 billion in 2023, with an expected annual growth rate of around 42%. By 2030, the market could reach $100 billion, according to research from Goldman Sachs.

BIO101 (20-hydroxyecdysone) has shown promising metabolic benefits on muscle and fat tissues in preclinical studies. These effects could lead to improved mobility and muscle strength in obese patients, particularly those suffering from muscle loss due to severe weight reduction. The SARA-INT phase 2 study suggested that BIO101 could benefit sarcopenic patients. Additionally, in the Quinolia study, this molecule was tested on obese patients on a hypocaloric diet, showing positive effects on muscle strength and fat mass loss.

Stanislas Veillet, CEO of Biophytis, emphasized the potential of BIO101 (20-hydroxyecdysone) to preserve muscle function in patients undergoing obesity treatment with GLP-1 receptor agonists. Subject to regulatory approvals, this drug candidate could address critical medical needs and position Biophytis favorably in a rapidly growing market. Veillet expressed confidence that their expertise in developing drugs for muscular diseases and the positive preclinical results in obesity would expedite the clinical plan for the OBA program.

The Phase 2 clinical study of the OBA program is expected to commence by mid-2024, pending regulatory approvals, with initial patient treatments starting in the latter half of 2024. The efficacy of BIO101 (20-hydroxyecdysone) will be evaluated in obese patients who are also treated with GLP-1 receptor agonists and are following a hypocaloric diet. The first efficacy results are anticipated to be available in 2025. Further details on the OBA program and clinical study will be shared in the coming weeks.

Biophytis SA, headquartered in Paris and Cambridge, Massachusetts, is a clinical-stage biotechnology firm dedicated to developing treatments for age-related diseases. Their lead drug candidate, BIO101 (20-hydroxyecdysone), is under development for multiple conditions including sarcopenia, Duchenne muscular dystrophy, and obesity. The company's shares are listed on Euronext Growth Paris and the Nasdaq Capital Market.