Veru Inc. (VERU), Wednesday announced positive topline safety results from the Phase 2b QUALITY clinical trial, evaluating 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.
The multicenter, double-blind, placebo-controlled, randomized, dose-finding trial found that the combination of Enobosarm 3mg and semaglutide had a positive safety profile with fewer gastrointestinal side effects, such as diarrhea, nausea, and GERD, compared to semaglutide alone.
Moreover, the combination therapy resulted in the highly selective loss of fat mass, accounting for 99 percent of the total weight lost, while preserving lean mass.
Based on these findings, the company has selected the enobosarm 3mg dose to advance into its proposed Phase 3 study. Additionally, it has submitted a request for an End of Phase 2 meeting with FDA, which is estimated to occur in the third quarter of calendar year 2025.
The meeting is expected to provide regulatory clarity on the design of its planned Phase 3 study, a double-blind, placebo-controlled study in older patients aged 60 or above who have obesity or who are overweight and who are eligible for treatment with GLP-1 RA.
The primary objective of the proposed Phase 3 study will be the effect of enobosarm on physical function measured by the Stair Climb Test at 24 weeks. Meanwhile, key secondary objectives will be to assess the effect of enobosarm on total lean mass, total fat mass, insulin resistance, and hemoglobin A1c at 24 weeks.
Notably, Veru is expecting topline efficacy and safety data for the Phase 2b extension maintenance study in the second quarter to assess whether enobosarm monotherapy prevents the fat and weight regain following discontinuation of semaglutide.
In the pre-market hours, Veru's stock is moving up 37.21 percent, to $0.69 on the Nasdaq.
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