Veru’s enobosarm shows increased fat loss, muscle preservation and safety

Veru (VERU) announced positive topline safety results from the Phase 2b QUALITY clinical study designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to enhance fat loss and to prevent muscle loss in older patients receiving semaglutide for chronic weight management. In the clinical trial, enobosarm and semaglutide GLP-1 RA combination had a positive safety profile. There were no increases in gastrointestinal side effects, no evidence of drug-induced liver injury and no increases in obstructive sleep apnea at any dose of enobosarm compared to placebo – semaglutide alone -. No treatment related serious adverse events were observed in the QUALITY study. Based on QUALITY trial data, enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program. Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects. Enobosarm 3mg added to semaglutide resulted in the highly selective loss of fat mass, accounting for 99% of the total weight lost, while preserving lean mass. Veru has requested an End of Phase 2 meeting with FDA to provide regulatory clarity on the Phase 3 clinical program. The topline efficacy and safety data for the Phase 2b extension maintenance study to assess whether enobosarm monotherapy prevents the fat and weight regain following discontinuation of semaglutide are expected in Q2. Veru is currently developing a novel, patentable, modified release oral formulation for enobosarm. The new enobosarm formulation has completed animal trials and is anticipated to be in Phase 1 bioavailability clinical trials during the first half of calendar 2025.