Veru Announces Date of 2024 Annual Meeting of Shareholders - Seite 2

The Company also has an FDA-approved commercial product, the FC2 Female Condom (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.

About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel daily oral selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss of both muscle and fat mass like that seen with GLP-1 RA treatment. The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to preservation of muscle mass with improvements in physical function as well as significant reductions in fat mass.

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.

The efficacy and safety clinical data that were generated from five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction with higher quality total weight loss while preserving muscle and physical function.

Planned Phase 2b enobosarm clinical trial design for potentially high quality weight loss
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in 90 sarcopenic obese or overweight elderly (>60 years of age) 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 endpoints are total body fat mass and physical function at 16 weeks. The IND has received FDA clearance, and the clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected calendar year-end 2024.