Biophytis Unveils Phase 2 OBA Obesity Study Design

Biophytis SA, a clinical-stage biotechnology firm based in Paris, France, and Cambridge, Massachusetts, recently unveiled the design of its phase 2 OBA clinical study targeting obesity with the investigational drug BIO101 (20-hydroxyecdysone). Biophytis specializes in developing therapeutics for age-related diseases, and this study is poised to further their efforts in the obesity treatment landscape.

BIO101, the company's lead drug candidate, will be assessed in obese patients who are undergoing treatment with GLP-1 receptor agonists (GLP-1 RAs) while also following a hypocaloric diet. The phase 2 OBA study intends to evaluate the efficacy and safety of BIO101 in patients with obesity or overweight conditions, particularly those who have secondary comorbidities and are beginning GLP-1 RAs treatment for weight reduction.

Stanislas Veillet, CEO of Biophytis, highlighted the significance of addressing this substantial medical challenge, which also represents a considerable market opportunity. Veillet expressed confidence in BIO101’s potential to maintain muscle function in obese patients undergoing weight loss treatments with GLP-1 RAs. He anticipates that, pending regulatory approvals, the drug candidate could progress to phase 2 clinical trials by mid-2024, with initial results expected in 2025.

The OBA Phase 2 trial is structured as a double-blind, randomized, placebo-controlled study that aims to enroll 164 patients with a Body Mass Index (BMI) of 30 or higher, or a BMI of 27 or higher with at least one related condition such as diabetes or hypertension. Participants will begin their treatment with GLP-1 RAs and maintain a hypocaloric diet. The study will administer a double-blind treatment with 350 mg of BIO101 twice daily for a duration of 21 weeks.

The primary endpoint of efficacy is set to be muscle strength, measured by knee extension. Secondary outcomes will include the 6-minute walking distance test, other performance tests, muscle strength adjusted for lean body mass, appendicular lean mass, fat mass, biomarkers, and various Patient-Reported Outcomes (PROs).

Biophytis is preparing to submit an Investigational New Drug (IND) application to initiate the OBA Phase 2 study in the United States in the coming weeks. The clinical study is expected to commence in mid-2024, contingent on regulatory approvals, with the first patient treatments slated for the latter half of the year. Initial results regarding the safety and efficacy of BIO101 are anticipated to be available in 2025.

Biophytis SA is dedicated to advancing drug candidates for age-related diseases. Besides obesity, BIO101 is being developed for other conditions such as sarcopenia and Duchenne muscular dystrophy, with some programs already reaching advanced clinical stages. The company’s ordinary shares are listed on Euronext Growth in Paris, and its ADSs are on the OTC market.

Biophytis continues to make strides in the biotechnology sector, focusing on significant medical challenges with promising therapeutic solutions. The upcoming phase 2 OBA clinical study represents a crucial step in their mission to develop effective treatments for obesity and its associated health issues.