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

FDA IND clearance is an important development milestone in advancing enobosarm in combination with GLP-1 drugs for potentially higher quality weight loss than has been shown with GLP-1 drug alone

Randomized Phase 2b clinical trial aims to show enobosarm preserves muscle and physical function while augmenting fat loss in sarcopenic obese or overweight elderly patients on GLP-1 drug for weight loss

Phase 2b clinical trial is expected to initiate by April 2024

Phase 2b clinical trial final topline results are anticipated by year-end

MIAMI, FL, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), 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), today 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.