Veru Reports Fiscal 2024 First Quarter Financial Highlights - Seite 2

In addition, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women dosed with duration of treatment in some patients for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increase in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

Initially, enobosarm will be developed in a Phase 2b clinical study to address the large subpopulation of sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness leading to physical function mobility disability and frailty.

Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial to evaluate enobosarm as a treatment to augment fat loss and to prevent muscle loss in receiving GLP-1 drug for weight loss.

We submitted an Investigational New Drug (IND) application for enobosarm in January 2024. In February 2024, the Company received FDA clearance to initiate the Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 90 sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness. The primary endpoint is lean body mass (muscle), and the key secondary endpoint is total body fat mass at 16 weeks. The clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue into an open label extension trial where all patients will receive 6 mg of enobosarm monotherapy for 12 weeks to determine the ability of enobosarm to rescue, or reverse muscle loss and prevent fat and weight rebound after stopping a GLP-1 RA. The results of the separate Phase 2b open label extension clinical study are expected in calendar Q2 2025.