Biophytis SA showcased its OBA (Obesity, muscle loss and Activity) clinical development program at the 17th international SCWD (Society on Sarcopenia, Cachexia & Wasting disorders) congress, presenting data supporting the potential of BIO101 (20-hydroxyecdysone) to counteract muscle mass and function loss in obese or overweight patients treated with GLP-1 receptor agonists (GLP-1 RAs). The company plans to initiate a Phase 2 clinical trial in early 2025 to further evaluate BIO101's efficacy in this population.
BIO101 Clinical Profile in Obesity
Rob van Maanen, Chief Medical Officer of Biophytis, presented the clinical profile of BIO101 in obesity, emphasizing its role in preventing muscle loss associated with GLP-1 RA therapies. GLP-1 RAs, such as semaglutide (Wegovy), are increasingly used for weight management but can lead to the unintended loss of muscle mass along with fat. The presentation, titled "BIO101 + GLP-1 RA to Prevent Potential Muscle Loss in Overweight and Obese Patients," highlighted findings from the Quinolia clinical study and a subgroup analysis of the SARA-INT study.
Quinolia Study Results
The Quinolia study was a double-blind, placebo-controlled trial involving 58 overweight and obese adults. Participants were treated with a low dose (37.5 mg/day) of 20-hydroxyecdysone (20E) over a 6-week hypocaloric diet period followed by a 6-week maintenance diet phase. Results indicated a nominally significantly greater reduction in android fat mass and adipocyte diameter in the 20E group compared to the placebo group. Furthermore, in patients who lost at least 5% of their body weight, muscle strength (measured by hand grip strength) was maintained in the 20E group, while it declined in the placebo group (p = 0.09), although this difference did not reach statistical significance.
SARA-INT Study Subgroup Analysis
An analysis of the sarcopenic obese patient subgroup from the Phase 2 SARA-INT study suggested a potential effect of BIO101 on muscle function. The subgroup treated with BIO101 showed a nominally statistically significant improvement in the 400-meter walking speed test.
Phase 2 OBA Study Design
Building on these findings, Biophytis is planning a Phase 2 OBA study, a double-blind, randomized, placebo-controlled clinical trial set to recruit 164 patients with obesity (BMI ≥30) or overweight (BMI ≥27 with comorbidities like hypertension). Participants will be initiating GLP-1 RA therapy combined with a hypocaloric diet. They will receive either 350 mg BID of BIO101 or a placebo over a 21-week period.
The primary efficacy endpoint is muscle strength, measured by knee extension. Secondary endpoints include the 6-minute walk distance, muscle strength normalized to lean mass, appendicular lean mass, fat mass, biomarkers, and patient-reported outcomes (PROs).
The trial is expected to begin in the first half of 2025, pending regulatory approvals for clinical centers in the United States and Europe. Initial safety and efficacy results for BIO101 are anticipated by late 2025 at the earliest.
Stanislas Veillet, CEO of Biophytis, stated, "This is the first time that Biophytis has presented its results in obesity at an international congress such as the SCWD... These results are very encouraging and confirm our determination to focus our clinical development strategy on our drug candidate BIO101 (20hydroxyecdysone). These results will also enable us to launch the phase 2 OBA clinical trial in obesity in early 2025."
