Veru Reports Safety and Body Composition Data at ADA's 84th Scientific Sessions

Veru Inc. (NASDAQ: VERU), a clinical stage biopharmaceutical company specializing in treatments for muscle preservation, oncology, and viral-induced acute respiratory distress syndrome, recently unveiled data from two significant late-breaker presentations at the American Diabetes Association's 84th Scientific Sessions held in Orlando, Florida from June 21-24, 2024.

The first presentation, Poster #2067-LB, focused on a pooled safety analysis of enobosarm, a selective androgen receptor modulator (SARM), from Phase 2 and Phase 3 placebo-controlled clinical trials. The analysis included 1,027 older men, postmenopausal women, and older patients with advanced cancer. Results indicated that enobosarm was generally well-tolerated, showing an adverse event profile similar to control patients. Importantly, there was no significant increase in gastrointestinal side effects with enobosarm compared to placebo. Elevated alanine transaminase (ALT) levels were observed in 3.7% of enobosarm-treated patients versus 1.4% in the placebo group. However, these ALT elevations were transient and mild, with no evidence of liver injury as per Hy’s Law. Cardiovascular adverse events were comparable between the groups, with deep vein thrombosis occurring less frequently in the enobosarm group (1.0%) than in the placebo group (3.3%).

The second presentation, Poster #2066-LB, discussed the potential of enobosarm to optimize weight loss through a meta-analysis of body composition data from three randomized clinical trials. The analysis, which included 367 older men, postmenopausal women, and older patients with muscle loss due to advanced cancer, demonstrated that enobosarm therapy effectively reduced fat mass by 6.26% compared to placebo, while preserving lean mass, which increased by 4.04% compared to placebo at day 84. These findings suggest that enobosarm, when used in conjunction with a GLP-1 receptor agonist, may promote high-quality weight loss by preserving muscle mass and preferentially reducing fat.

In addition to presenting these findings, Veru Inc. provided an update on its ongoing Phase 2b clinical trial of enobosarm. This trial is a multicenter, double-blind, placebo-controlled, randomized study aimed at evaluating the safety and efficacy of enobosarm in 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide (Wegovy®). The primary endpoint is the change in total lean body mass, with secondary endpoints including total body fat mass and physical function as measured by a stair climb test at 16 weeks. The trial is actively enrolling patients across 15 clinical sites in the United States, with topline results anticipated by the end of 2024.

Following the completion of the efficacy portion of the Phase 2b trial, participants will move into a blinded extension trial for an additional 12 weeks, where they will cease GLP-1 RA treatment but continue with either placebo, enobosarm 3mg, or enobosarm 6mg. This extension aims to evaluate the ability of enobosarm to maintain muscle mass and prevent the fat and weight gain that often occurs post-GLP-1 RA therapy. Results from this extension study are expected in the second quarter of 2025.

Enobosarm has previously been studied in five clinical trials involving 968 older men and postmenopausal women, as well as patients with advanced cancer. These studies have shown that enobosarm can increase muscle mass and improve physical function while also reducing fat mass. The extensive safety database, which includes data from 27 clinical trials involving 1581 men and women, supports its tolerability with no significant gastrointestinal side effects.

Veru Inc. continues to advance its drug development program, which includes the development of enobosarm for metabolic diseases, oncology, and acute respiratory distress syndrome. The company's innovative approach aims to address significant unmet medical needs in these areas.