Veru Inc., a biopharmaceutical company in the late stages of clinical development, focusing on innovative treatments for muscle preservation, oncology, and viral-induced acute respiratory distress syndrome, announced its participation in the World Obesity and Weight Management Congress scheduled for October 24-26, 2024, in Baltimore, Maryland. The company is set to present a keynote on October 25, 2024, discussing the advancement of enobosarm, an oral Selective Androgen Receptor Modulator (SARM), aimed at preventing muscle loss and enhancing fat loss when paired with Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) drugs. The presentation will occur from 9:40 AM to 10:20 AM Eastern Daylight Time at the Best Western Plus Hotel & Conference Center in Baltimore.
The Phase 2b clinical trial of enobosarm is a multicenter study designed to assess the safety and efficacy of enobosarm doses of 3mg and 6mg, compared to a placebo, in preserving muscle and reducing fat in 168 patients with sarcopenic obesity or overweight elderlies receiving semaglutide (Wegovy ®). The primary endpoint is total lean body mass, with secondary endpoints being total body fat mass and physical function, measured by a stair climb test at 16 weeks. The trial is currently enrolling participants across up to 15 sites in the United States, with results expected in January 2025.
Following the completion of the dose-finding phase, participants will be blindly transitioned to an extension study, continuing with placebo, enobosarm 3mg, or enobosarm 6mg for another 12 weeks, but ceasing GLP-1 RA treatment. This part of the trial aims to evaluate whether enobosarm can sustain muscle mass and prevent fat and weight gain post-GLP-1 RA cessation. Results from this phase are anticipated in the second quarter of 2025.
Sarcopenic obesity, a condition affecting up to 34.4% of obese individuals over 60 in the U.S., necessitates caution when using GLP-1 treatments due to associated muscle mass loss risks. This condition can escalate into frailty if exacerbated by GLP-1 RA-induced muscle depletion.
Enobosarm, also known as ostarine, has been tested in previous clinical trials involving nearly 1,600 participants, including elderly individuals and cancer patients experiencing muscle wasting. These studies demonstrated enobosarm’s potential to increase muscle mass and improve physical function, alongside reducing fat mass. The safety profile across 27 clinical trials suggested good tolerance, especially important given the gastrointestinal side effects associated with GLP-1 RA treatments.
Veru Inc. is advancing its drug development program with enobosarm, also targeting breast cancer treatment in Phase 3 trials, contingent upon funding. Another product, sabizabulin, is in development for treating viral-induced ARDS, with further progress dependent on external financial support.
The company’s portfolio also includes the FC2 Female Condom, approved for preventing unplanned pregnancy and sexually transmitted infections. Veru’s strategic focus on obesity and oncology signifies its commitment to addressing critical health challenges.
The company outlined forward-looking statements in their release, emphasizing ongoing developments, potential outcomes, and associated risks. These statements are guided by current plans and are subject to change based on new information or circumstances. Risks include uncertainties in trial progress, funding challenges, and regulatory approvals.
Further details are disclosed in Veru’s SEC filings, and the company’s investor contact is Samuel Fisch, who can be reached via the provided email address. Wegovy® is a Novo Nordisk registered trademark.
