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

Veru Inc. has unveiled promising topline data from its Phase IIb QUALITY study, demonstrating that its investigational selective androgen receptor modulator (SARM) enobosarm can significantly improve the quality of weight loss in older adults with obesity or overweight who are taking Novo Nordisk's popular GLP-1 receptor agonist, Wegovy (semaglutide).

Enobosarm Preserves Lean Mass in Combination with Wegovy

The 16-week study enrolled 168 patients aged 60 years and older, with 100 randomized to receive either 3mg or 6mg of enobosarm daily alongside their weekly Wegovy injections, while the remainder received a placebo. Key findings include:

• Patients taking enobosarm in addition to Wegovy experienced 71% less lean mass loss compared to those taking Wegovy alone, with a highly statistically significant p-value of 0.002.
• The enobosarm group lost an average of 1.2% of their lean body mass, compared to 4.1% in the Wegovy-only group.
• Enobosarm recipients also saw a significant 27% greater fat loss than controls.
• Fewer patients taking enobosarm experienced a 10% or greater decline in stair climb power (19.4% vs. 42.6% in the placebo group).

Veru CEO Mitchell Steiner 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."

Industry Implications and Competitive Landscape

The development of enobosarm comes as the pharmaceutical industry seeks to address the limitations of current obesity treatments, particularly the loss of lean mass associated with GLP-1 receptor agonists. This focus on improving body composition alongside weight loss is gaining traction, especially for older patients at risk of frailty and functional decline.

Other companies exploring similar approaches include:

• Regeneron, which announced plans to advance two muscle-sparing antibodies, trevogrumab and garetosmab, for testing in combination with incretin-based weight loss medicines.
• Altimmune, whose investigational drug pemvidutide has shown strong weight reduction with over 71% attributable to fat loss.
• Eli Lilly, which recently partnered with Chinese biotech Laekna to develop an antibody that induces weight loss while preserving muscle mass.

Next Steps and Market Response

Despite the positive results, Veru's stock price fell by nearly 50% following the announcement, trading at 65 cents per share in late morning trading. The company plans to meet with the FDA to determine the best path forward for enobosarm, including the design of its Phase III program.

Veru anticipates a similar trial design for Phase III, but with an increased patient population of 470 and an extended duration of 52 weeks. The primary goal will be to measure changes in stair-climb power, reflecting the focus on preserving physical function in older adults undergoing weight loss treatment.

As the obesity treatment landscape continues to evolve, the development of adjunct therapies like enobosarm may play a crucial role in addressing the complex needs of patients, particularly those at risk of losing muscle mass during weight loss interventions.