Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle during weight loss, oncology, and viral-induced acute respiratory distress syndrome [13] - The company's drug development program includes enobosarm and sabizabulin, with enobosarm being a selective androgen receptor modulator (SARM) [14][15] Clinical Trials and Results - The Phase 2b QUALITY clinical trial evaluated enobosarm in combination with semaglutide for preserving muscle and enhancing fat loss in 168 patients aged over 60 with sarcopenic obesity [3] - The trial met its primary endpoint, showing a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (p=0.002) [4] - Enobosarm 3mg + semaglutide demonstrated a >99% mean relative reduction in lean mass loss (p <0.001), while the 6mg dose did not show superior results [4] - Secondary endpoints indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014) [5] - The treatment improved body composition, with 90.6% of weight loss in the enobosarm + semaglutide group attributed to fat loss compared to 68% in the placebo group [5] Physical Function and Safety - The Stair Climb Test showed that 54.4% of patients in the enobosarm + semaglutide group had a significant reduction in the proportion of subjects losing at least 10% stair climb power compared to the placebo group (p=0.004) [6] - Safety data remains blinded, but no significant differences have been observed compared to previous studies of enobosarm [7] - An Independent Data Monitoring Committee recommended continuing the study based on unblinded safety data [8] Market Potential - The market for sarcopenic obesity is substantial, with 22% of the US population over 60 years old and 42% of older adults classified as obese [9] - Up to 34% of obese patients over 60 may have sarcopenic obesity, which poses risks when using GLP-1 drugs for weight reduction [9][10] Future Plans - Following positive topline results, the company plans to request an end of Phase 2 meeting with the FDA [8]
Veru to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference