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

Biophytis / Key word(s): Miscellaneous/Miscellaneous Biophytis announces the design of its phase 2 OBA clinical study in obesity 14-May-2024 / 07:00 CET/CEST Biophytis announces the design of its phase 2 OBA clinical study in obesity

Paris (France) and Cambridge (Massachusetts, USA), May 14, 2024 – 07:00 am CET – Biophytis SA (Euronext Growth Paris : ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the  development of  therapeutics for age-related diseases, today 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.