Muscle loss due to obesity treatment: no therapy available today

Worldwide, around 1 billion people live with obesity. Obesity is a chronic disease characterized by an excessive amount of body fat that disrupts the body’s normal function. The World Health Organization defines obesity as having a Body Mass Index (BMI) of 30 or higher. Obesity increases the risk of various health problems, including type 2 diabetes, heart disease, stroke, sleep apnea and osteoarthritis. Managing obesity often involves a multi-pronged approach including diet and medications.

GLP-1 receptor agonists (GLP-1 RAs) are a class of medications used to treat type 2 diabetes and increasingly for obesity management. They work by mimicking a natural gut hormone called Glucagon-like peptide-1 (GLP-1) which slows down digestion, increases insulin production and reduces appetite. These effects can lead to reduced calorie intake and weight loss.

While effective for weight loss, GLP-1 RAs do have an important downside: muscle loss. This means that a portion of the weight lost while taking these medications comes from muscle tissue, not just fat. Research suggests that up to 40% of weight loss with GLP-1 RAs could be lean mass.


Biophytis has already obtained promising results in obesity

BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical studies in obesity. These beneficial effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study. Furthermore, the 20-hydroxyecdysone molecule was already tested in obese patients during hypocaloric dieting in the Quinolia study, showing promising effects on muscle strength and fat mass loss.


An accelerated clinical development with results expected in 2025

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. Biophytis’ leadership in developing drugs for muscular diseases and promising results obtained in obesity will be a strong accelerator of the OBA clinical plan.

The OBA phase 2 study will test the efficacy and safety of BIO101 (20-hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 RAs for weight loss. The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, appendicular lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs).

OBA Phase 2 study is expected to start in mid 2024, upon regulatory approvals, with the first patient to be enrolled in the second half of 2024. BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs and following hypocaloric dieting. The completion of the OBA Phase 2 study and report of its results are expected in 2025.