Veru's Enobosarm Shows Promise in Preserving Muscle Mass for Wegovy Patients

In a significant development for the obesity treatment landscape, Veru Inc. has unveiled promising topline data from its Phase IIb QUALITY study, demonstrating that its investigational drug enobosarm can effectively preserve lean mass in overweight and obese adults taking Novo Nordisk's popular weight loss medication, Wegovy.

Enobosarm's Impact on Lean Mass Preservation

The 16-week study revealed that patients receiving enobosarm in addition to Wegovy experienced 71% less lean mass loss compared to those taking Wegovy alone. This difference was highly statistically significant, with a p-value of 0.002. Furthermore, the enobosarm group saw a 27% greater reduction in fat mass compared to the control group.

Mitchell Steiner, CEO of Veru, emphasized the importance of these findings, stating, "Older patients who are overweight or have obesity and receiving only a Wegovy (semaglutide) GLP-1 RA are at higher risk for accelerated frailty and functional decline." He added that the potential for further reduction in physical function due to ongoing lean mass loss with chronic GLP-1 RA therapy is a concern that requires evaluation.

Functional Improvements and Study Details

The QUALITY study, which involved 168 patients aged over 60 years, also demonstrated functional benefits. Fewer patients in the enobosarm group experienced a 10% or greater decline in stair climb power compared to the placebo group. Specifically, 19.4% of enobosarm patients experienced this decline, versus 31.9% in the placebo group.

While the safety data from the trial remain blinded, Veru reported that the latest study had not shown significant differences compared to previous trials of enobosarm. Based on these promising results, Veru plans to meet with the FDA to discuss the design of a potential Phase III program for enobosarm.

Industry Implications and Competition

The development of enobosarm comes at a time when the pharmaceutical industry is seeking ways to improve upon the current generation of obesity treatments. While GLP-1 receptor agonists like Wegovy have shown significant efficacy in weight loss, concerns about lean mass loss have emerged. Wegovy has been associated with lean mass loss of up to 40% at the end of 68 weeks of treatment.

Several other companies are also working on addressing this challenge. Regeneron announced plans to advance two muscle-sparing antibodies, trevogrumab and garetosmab, for testing in combination with incretin-based weight loss medicines. Altimmune's pemvidutide has shown strong weight reduction with over 71% attributable to fat loss. Additionally, Eli Lilly recently partnered with Chinese biotech Laekna to develop an antibody that induces weight loss while preserving muscle mass.

As the obesity treatment market continues to evolve, the focus on quality of weight loss—specifically targeting fat mass while preserving muscle—represents a new frontier in drug development. The results from Veru's QUALITY study suggest that enobosarm could play a significant role in this emerging field, potentially offering a valuable complement to existing GLP-1 receptor agonist therapies.