Veru Enrolls First Patients in Phase 2b Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss

-- The Phase 2b study planned to be conducted in 15 clinical sites in the United States --

-- Topline clinical data expected in the fourth quarter calendar year 2024 --

MIAMI, FL, April 30, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that it has enrolled the first patients in its Phase 2b clinical trial of enobosarm, an oral selective androgen receptor modulator (SARM), to avoid muscle loss and to augment fat loss when combined with semaglutide (Wegovy), a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug, for potentially higher quality weight loss. Topline clinical data is expected in the fourth quarter of the calendar year 2024.

"We are excited to enroll the first patients in the Phase 2b clinical trial, marking an important milestone in the development of enobosarm for high quality weight loss,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “There is a significant unmet medical need to have a drug that may effectively preserve muscle in patients undergoing weight loss therapy with GLP-1 drugs. Patients receiving GLP-1 drugs lose significant muscle as part of the weight loss which can lead to muscle weakness in older patients with both obesity and low muscle reserves. Muscle weakness is associated with mobility disability and loss of balance resulting in a higher risk for falls and hip and pelvic fractures. In fact, the package insert for Wegovy has been updated based on the recently reported SELECT (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) cardiovascular outcomes clinical trial to highlight the four-fold increase in pelvic and hip fractures that was observed in patients greater than 75 years of age receiving Wegovy compared to placebo.”

“While there is clear medical benefit from weight loss with semaglutide, improving weight loss quality by minimizing the loss of lean mass is the next step forward in improving metabolic complications of obesity. This Phase 2b clinical trial of enobosarm will provide important insights into how this goal can be achieved,” said Louis Aronne, MD, obesity medicine specialist at Weill Cornell Medicine in New York, Chief Medical Advisor to Veru*.