Biophytis launches trial targeting muscle loss in GLP-1 obesity treatment

Company aims to counter the loss of muscle mass and function during weight-loss efforts when combined with GLP-1 receptor agonists.

Longevity biotech Biophytis has announced the launch of a Phase 2 clinical study to explore the use of its oral daily MAS receptor activator (BIO101) in the treatment of obesity, in conjunction with GLP-1 receptor agonists such as Wegovy and Ozempic. The trial, dubbed OBA, aims to address a critical gap in obesity treatment — the loss of muscle mass and function during weight-loss efforts.

Biophytis claims that GLP-1 receptor agonist drugs, known for their efficacy in inducing substantial weight loss and thought to have longevity-boosting potential, can inadvertently lead to muscle depletion, accounting for up to 40% of total weight loss. This loss is concerning due to the pivotal role muscle tissue plays in metabolic regulation and motor function. There are currently no approved drugs specifically targeting muscle loss resulting from obesity treatment.

Headquartered in Paris, France, and Cambridge, Massachusetts, Biophytis specializes in developing drug candidates for age-related diseases, and BIO101 (20-hydroxyecdysone) is the company’s lead candidate, with multiple ongoing clinical-stage programs in muscular, respiratory, and metabolic diseases.

BIO101 has shown promise in Biophytis’ preclinical studies for obesity, demonstrating metabolic effects on both muscle and fat tissues. The drug was also shown to potentially enhance mobility and muscle strength in obese sarcopenic patients, as suggested by the company’s SARA-INT Phase 2 study, and has also exhibited favorable effects on muscle strength and fat mass loss in obese patients undergoing hypocaloric dieting.

With the impending OBA study set to commence in mid-2024, pending regulatory approvals, Biophytis aims to evaluate the efficacy of BIO101 (20-hydroxyecdysone) in obese patients undergoing GLP-1 RA treatment and hypocaloric dieting. Initial results are anticipated in 2025.

“We believe BIO101 (20-hydroxyecdysone) has the potential to be the molecule of choice for preserving muscle function in patients suffering from obesity who are treated with GLP-1 Ras,” said Stanislas Veillet, CEO of Biophytis. “Our drug candidate, subject to regulatory approvals, could contribute to meeting crucial medical challenges, while positioning Biophytis in a large market with incredibly high growth potential.”

According to Biophytis, more than 15 million adults in the US are anticipated to undergo anti-obesity medication treatment by 2030, or 13% of the adult population. Citing research from Goldman Sachs, the company says the obesity treatment market, currently estimated at $6 billion, is projected to grow at around 42% per year to reach $100 billion by 2030.