Veru's Enobosarm Shows Promise as Muscle-Sparing Obesity Treatment

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

Safety Profile and Gastrointestinal Side Effects

The Phase 2 trial results released on Wednesday indicate that the combination of enobosarm and Wegovy may lead to fewer gastrointestinal side effects compared to Wegovy alone. Specifically, at the enobosarm dose planned for Phase 3 testing, fewer participants experienced nausea, heartburn, diarrhea, or vomiting. However, the study did reveal a higher incidence of elevated liver enzymes in enobosarm-treated patients, although these levels subsequently decreased during the trial.

Muscle Preservation and Body Composition

While enobosarm did not enhance weight loss when used in conjunction with Wegovy, it demonstrated significant benefits in preserving lean muscle mass. In the 168-person trial, which focused on individuals with obesity aged 60 and older, the addition of enobosarm to Wegovy resulted in only a 1.2% loss of lean body mass, compared to a 4.1% loss in the Wegovy plus placebo arm. This finding addresses a growing concern in obesity treatment, as drugs like Wegovy and Eli Lilly's Zepbound have been shown to reduce both fat and lean muscle mass, potentially increasing the risk of premature frailty in older patients.

Future Developments and Market Potential

Veru is preparing to advance enobosarm to Phase 3 trials, focusing on the 3 milligram daily dose, which showed the most promising results without additional benefits at higher doses. The company is also developing a novel, patentable, modified-release oral formulation for Phase 3 testing and potential commercialization. This new formulation is expected to undergo Phase 1 trials in the coming weeks and could extend Veru's market exclusivity for enobosarm to 2045.

Despite the positive safety data, Veru's stock price remains below its January levels, when topline weight-loss data was initially released. However, the latest announcement led to a significant increase in share value during Wednesday morning trading, reflecting renewed investor interest in the potential of enobosarm as a muscle-sparing obesity treatment.