MIAMI, FL, April 16, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced that the Company will present at the 2nd Annual GLP-1-Based Therapeutics Summit, taking place April 29 - May 1, 2025, in Boston, Massachusetts.Presentation Title: Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass and Physical Function in Older Patients Receiving Semaglutide for Weight LossDate: April 30, 2025Start time: 12:30 PM Eastern Standard TimeLocation: Wyndham Boston Beacon Hill, Boston, MAAdditional information on the meeting can be found on the following website: https://glp-1-based-therapeutics.com/About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.Obesity Program- enobosarm is a next generation drug that makes weight reduction by GLP-1 RA more tissue selective for fat loss- Phase 2b QUALITY clinical study.On January 27, 2025, the Company announced positive topline results from its Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding QUALITY clinical trial to evaluate enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve lean body mass and augment loss of fat in 168 obese or overweight older (>60 years of age) patients receiving semaglutide (Wegovy®).The trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in the preservation of total lean body mass in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks (71% relative reduction in lean mass loss, p=0.002). The enobosarm 3mg + semaglutide was the best dose with a >99% mean relative reduction in loss of lean mass (p 0.001).As for secondary clinical endpoints, enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide, with the enobosarm 6mg dose + semaglutide group having a 46% greater relative loss of fat mass compared to the placebo + semaglutide group at 16 weeks (p=0.014). Although enobosarm + semaglutide significantly preserved lean mass, the additional loss of fat mass caused by enobosarm treatment was able to replace the lean mass preserved to allow a similar net mean weight loss with semaglutide at 16 weeks. Accordingly, the tissue composition of the total weight loss shifted to greater and selective loss of fat with enobosarm treatment. The median percentage of total body weight loss in the placebo + semaglutide group that was due to lean mass was 32% and estimated fat loss was 68%. In contrast, in the all enobosarm + semaglutide group, the median total weight loss due to lean mass was 9.4% vs estimated fat loss of 90.6% meaning the all enobosarm + semaglutide group experienced approximately 33.2% more fat loss relative to the placebo + semaglutide group, and for the enobosarm 3mg + semaglutide group, it was 0.9% lean mass vs 99.1% estimated fat loss, meaning the enobosarm 3mg + semaglutide group experienced approximately 45.7% more fat loss relative to the placebo + semaglutide group. Therefore, enobosarm + semaglutide improved changes in body composition resulting in more selective and greater loss of adiposity than in subjects receiving placebo + semaglutide.Physical function was measured by the Stair Climb Test. Climbing stairs is an activity of daily living, and the Stair Climb Test measures functional muscle strength, balance and agility. Declines in performance measured by Stair Climb Test predicts higher risk for mobility disabilities, gait difficulties, hospitalizations, falls, and bone fractures in older patients. As a point of reference, stair climb power declines by -1.38% annually with aging.A responder analysis was conducted using a ≥10% decline in stair climb power as the cut off at 16 weeks which represents 7 to 8 year loss of stair climb power function due to aging. In our study, the loss of lean mass mattered as 42.6% of patients on placebo + semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. This is the first human study to demonstrate that older patients who are overweight or have obesity receiving semaglutide GLP-1 RA are ...Full story available on Benzinga.com
