On Friday, H.C. Wainwright affirmed its Buy rating and $15.00 price target for Biophytis SA (NASDAQ:BPTS) stock, following the company's announcement that it received FDA approval to commence a Phase 2 clinical study. The study, which will focus on BIO101 in obese patients, is set to begin in mid-2024 in the United States, with the possibility of expanding into Europe.
The Phase 2 trial, named OBA, is designed as a double-blind, randomized, placebo-controlled study that will involve 164 patients. These patients will either have a Body Mass Index (BMI) of 30 kg/m2 or higher or a BMI of 27 kg/m2 with at least one additional sequelae. Participants will be treated with 350 mg of BIO101 twice daily alongside a GLP-1 receptor agonist (RA) and a calorie-restricted diet.
The primary goal of the trial is to evaluate improvements in muscle strength in the lower limbs, particularly through knee extension exercises. Secondary objectives will include assessments of mobility, using the 6-minute walk test, and body composition, focusing on the analysis of fat and lean mass. The initial results from the study are expected to be available in 2025.
Biophytis has expressed its continued commitment to securing more funding and partnerships to support the completion of the clinical development for this program. The company's efforts are geared towards addressing the need to preserve muscle mass, strength, and function in obese patients who are undergoing treatment with GLP-1 RAs, a topic detailed in H.C. Wainwright's previous report.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.