Veru Announces FDA Clearance of IND Application to Initiate Phase 2b Clinical Trial with Enobosarm to Treat Muscle Loss Associated with Weight Loss Drugs

Veru Inc., a late clinical stage biopharmaceutical company focused on developing innovative medicines for potentially higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its Phase 2b clinical study to evaluate enobosarm, an oral novel selective androgen receptor modulator (SARM), to preserve muscle mass and physical function and further increase fat loss in patients receiving a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug for potentially higher quality weight loss.

GLP-1 RA drugs are very effective drugs that result in significant weight loss. Unfortunately, studies have shown that up to 50% of the total weight loss comes from muscle which is problematic as muscle is essential for metabolism, strength, and physical function.

Planned Phase 2b enobosarm clinical trial design for potentially higher 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 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 by 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, 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 is expected in calendar Q2 2025.

“FDA clearance of our IND will allow us to evaluate enobosarm as a combination treatment with GLP-1 drugs to prevent the loss of muscle, while preferentially reducing fat in not only overweight or obese patients, but especially for the large subpopulation of sarcopenic obese or overweight elderly patients who are at-risk for developing muscle atrophy and muscle weakness leading to frailty,” stated Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “We look forward to starting the Phase 2 clinical study to further validate enobosarm’s ability to preserve muscle and physical function while augmenting fat loss to provide for a potentially higher quality weight loss.”