Biophytis announces the design of its phase 2 OBA clinical study in obesity

Biophytis announces the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone).

BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. 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.

Stanislas Veillet, CEO of Biophytis, stated: “It is crucial for Biophytis to position itself on this gigantic medical challenge which also presents a great potential market. 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 for weight loss with GLP-1 RAs. We are confident that our drug candidate, subject to regulatory approvals, could enter into a phase 2 clinical trial mid 2024 and that first results could be reported in 2025″.

The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI ≥30) or overweight (BMI ≥27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1 RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20-hydroxyecdysone) will be given for 21 weeks.

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).
Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks.
The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024.

First results of the safety and efficacy of BIO101 (20-hydroxyecdysone) drug candidate are expected to be available in 2025.