Veru's Muscle-Sparing Obesity Drug Enobosarm Shows Promise in Phase 2 Trial

Veru Inc. has reported positive safety results from a Phase 2 clinical trial of its muscle-preserving obesity drug enobosarm, paving the way for a planned Phase 3 study. The trial, which combined enobosarm with Novo Nordisk's popular weight-loss medication Wegovy, demonstrated potential benefits in reducing gastrointestinal side effects and preserving lean muscle mass in older adults with obesity.

Safety Profile and Side Effects

The Phase 2 trial results indicate that the combination of enobosarm and Wegovy may offer a more tolerable treatment option for patients. According to Veru, fewer participants experienced nausea, heartburn, diarrhea, and vomiting when taking the combination therapy compared to those on Wegovy alone. This improved side effect profile was particularly notable at the 3 mg dose of enobosarm, which is the planned dosage for the upcoming Phase 3 trial.

However, the study did reveal a potential concern with liver enzyme elevations in some participants receiving enobosarm. The company reported that these levels subsequently decreased during the trial, with only one mild case observed at the 3 mg dose, which resolved while the patient continued treatment.

Muscle Preservation and Body Composition

While the addition of enobosarm to Wegovy did not enhance overall weight loss, it demonstrated significant benefits in preserving lean body mass. Participants receiving the combination therapy experienced only a 1.2% loss in lean body mass, compared to a 4.1% loss in those taking Wegovy with a placebo. This finding is particularly relevant for older adults with obesity, as maintaining muscle mass is crucial for preventing frailty and maintaining physical function.

The trial also assessed physical function through a stair-climb power test. Fewer participants in the enobosarm group experienced substantial losses in this measure of functional capacity, further supporting the drug's potential to preserve muscle strength and mobility in older adults undergoing weight loss treatment.

Next Steps and Market Implications

Veru is now preparing for a Phase 3 trial of enobosarm, focusing on the 3 mg dose that showed the most promising balance of efficacy and safety. In a strategic move to extend market exclusivity, the company is developing a novel, patentable, modified-release oral formulation of enobosarm. This new formulation is set to undergo Phase 1 trials in the coming weeks and could potentially extend Veru's market exclusivity for enobosarm to 2045.

The news of these positive results has had a notable impact on Veru's stock, with shares rising significantly following the announcement. However, at around 60 cents per share, the stock remains below its previous high of $1.28, which was reached before the release of topline weight-loss data in January.

As the obesity treatment landscape continues to evolve, Veru's enobosarm represents a potential innovation in addressing the complex needs of older adults with obesity. By targeting muscle preservation alongside weight loss, the drug could offer a unique approach in a market dominated by GLP-1 receptor agonists like Wegovy and Eli Lilly's Zepbound.