HC Wainwright on Friday affirmed its buy rating and $15.00 price target on Biophytis SA (NASDAQ:BPTS) stock, following the company’s announcement that it has received FDA approval to begin a Phase 2 clinical study. The study, which will focus on BIO101 in patients with obesity, is scheduled to begin in mid-2024 in the U.S., with potential expansion into Europe.
The second phase of the trial, called OBA, is designed as a randomized, double-blind, placebo-controlled study and will include 164 patients. These patients will have a body mass index (BMI) of 30 kg/m2 or higher or a BMI of 27 kg/m2 with at least one additional complication. Participants will be treated with 350 mg of BIO101 twice daily in combination with a GLP-1 receptor agonist (RA) and a calorie-restricted diet.
The primary goal of the trial is to assess improvement in lower limb muscle strength, particularly through knee extension exercises. Secondary goals include assessment of mobility, using a 6-minute walk test, and body composition, with a focus on fat and lean mass. Initial results from the study are expected to be available in 2025.
BioVites has expressed its continued commitment to securing additional funding and partnerships to support the completion of clinical development of this program. The company’s efforts are directed toward addressing the need to preserve muscle mass, strength, and function in obese patients treated with GLP-1 RAs, a topic detailed in the previous HC Wainwright report.
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