Veru Reaches Full Enrollment for Phase 2b Quality Study of Enobosarm for Obesity

Overview

Veru Inc., a late clinical stage biopharmaceutical company, provided a business update including progress on its phase 2b QUALITY clinical trial and announced financial results for its fiscal 2024 third quarter.

Words from Chairman: Veru Inc

• We are very pleased to have expeditiously reached our targeted full enrollment of greater than 150 patients for our enobosarm phase 2b QUALITY clinical trial for muscle preservation for high quality weight loss in patients on treatment with a GLP-1 receptor agonist,"" said Mitchell Steiner, M.D., chairman, president, and chief executive officer of Veru Inc. 
• I am most appreciative for all the great work done to complete enrollment by our clinical sites, our investigators, the Veru clinical operations team, and the full Veru team. Having reached this important milestone, we now anticipate topline data in January 2025.""
• There is a substantial unmet medical need for a drug that can effectively preserve muscle mass while enhancing fat loss in patients using GLP-1 drugs for weight management,"" said Dr. Steiner. 
• Over the past quarter, we presented data at numerous prestigious scientific conferences and meetings, highlighting enobosarm's benefits in muscle preservation, physical function improvement, and safety as demonstrated in 5 previous enobosarm muscle clinical trials. We are enthusiastic about enobosarm's potential to address the muscle loss and physical function challenges in our phase 2b QUALITY clinical trial.”

About Phase 2b Study

• 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 preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy). 
• The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks.

After completing the efficacy dose-finding portion of the phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA.

Total Sites for Trial

• The clinical study is being conducted in 14 clinical sites in the United States. 
• Full patient enrollment has been reached for the approximately 150 patients in the phase 2b QUALITY study. 
• The company now anticipates that the last patient to complete the phase 2b QUALITY study will be in December 2024 with top line clinical results for the phase 2b QUALITY clinical trial expected in January 2025. 
• Furthermore, the topline results for the separate blinded phase 2b extension clinical study may now be expected in the second calendar quarter of 2025.

Obesity in The US

• According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. 
• Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. 
• This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. 
• Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. 
• Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.

About Enobosarm

• Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. 
• Advanced cancer causes the loss of appetite where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. 
• We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. 
• The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced appetite suppression provide strong clinical rationale for enobosarm. 
• The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.

Safety Database of Enobosarm

• Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1,581 men and women, some of which included patients dosed for up to 3 years. 
• In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. 
• This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!