Veru to Speak at GLP-1 Therapeutics Summit
MIAMI, FL, May 02, 2024-- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company in the advanced clinical stages, is concentrating on creating innovative treatments that preserve muscle mass during weight loss, cancer therapy, and acute respiratory distress syndrome caused by viruses. The company announced its participation in the GLP-1 Based Therapeutics Summit in Philadelphia, PA, from May 15-16, 2024.
At the summit, Veru Inc. will present insights on their latest development, Enobosarm, an oral selective androgen receptor modulator (SARM). This presentation will discuss how combining Enobosarm with GLP-1 receptor agonist (GLP-1 RA) drugs could prevent muscle loss and enhance fat loss, potentially resulting in higher quality weight loss. The presentation is set for May 16, 2024, from 9:00 AM to 9:30 AM Eastern Daylight Time.
The presentation will address several key issues, including the role of muscle loss in causing weight loss plateaus with GLP-1 receptor agonists, the rebound of fat and weight upon discontinuation of GLP-1 RA, and the acceleration of frailty in older, sarcopenic obese patients. Additionally, Veru Inc. will present findings from five clinical studies involving Enobosarm, which support their ongoing Phase 2b clinical trial combining Enobosarm with GLP-1 RA.
The Phase 2b clinical trial is a multicenter, double-blind, placebo-controlled, randomized study designed to assess the safety and efficacy of Enobosarm at dosages of 3mg and 6mg, compared to a placebo. The trial involves approximately 90 participants with sarcopenic obesity or overweight elderly patients receiving semaglutide (Wegovy®). The primary endpoint is the difference in total lean body mass measured by DEXA. Key secondary endpoints include differences in total body fat mass and physical function as measured by a stair climb test at 16 weeks. Topline results from this trial are anticipated by the end of 2024.
Following the completion of the initial Phase 2b trial, participants will enter an extension phase where GLP-1 RA treatment is discontinued, but Enobosarm or placebo will continue for another 12 weeks. This extension will evaluate Enobosarm's ability to maintain muscle mass and prevent the typical fat and weight regain after stopping GLP-1 RA therapy. Results from this extension phase are expected in the second quarter of 2025.
Sarcopenic obesity, a condition that affects many elderly adults in the United States, is characterized by an age-related decline in muscle mass combined with obesity. According to the CDC, 41.5% of older adults in the U.S. are obese, and up to 34.4% of these individuals also suffer from sarcopenic obesity. The use of GLP-1 RA drugs in these patients can exacerbate muscle loss, leading to considerable health risks such as poor balance, decreased mobility, and increased mortality.
Enobosarm has been studied extensively in prior clinical trials, involving 968 older adults and cancer patients. These studies demonstrated that Enobosarm can increase muscle mass and improve physical function while also reducing fat mass. Importantly, Enobosarm has shown a favorable safety profile over 27 clinical trials involving 1581 participants, making it a promising candidate for combination therapy with GLP-1 RA drugs.
Veru Inc. is committed to advancing its drug development program, which also includes the Phase 3 ENABLAR-2 clinical trial of Enobosarm for metastatic breast cancer. Additionally, the company is developing Sabizabulin for treating viral-induced ARDS and markets the FC2 Female Condom® for dual protection against pregnancy and sexually transmitted infections.
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