Veru To Present At The GLP-1 Based Therapeutics Summit
Veru Inc. (NASDAQ:VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company has been invited to give a presentation at the GLP-1 Based Therapeutics Summit, taking place May 15-16, 2024, in Philadelphia, PA.
Presentation details:
Advancing Enobosarm, An Oral Novel Selective Androgen Receptor Modulator (SARM), to Avoid Muscle Loss and Augment Fat Loss When Combined with a Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Drugs for Potentially Higher Quality Weight Loss
Date: Thursday, May 16, 2024
Start and end time: 9:00 AM – 9:30 AM Eastern Daylight Time
- Highlighting the concerns that (i) muscle loss caused by GLP-1 receptor agonists may be partly responsible for weight loss plateau, (ii) upon stopping GLP-1 RA, the fat and weight rebound regain, and (iii) such muscle loss may accelerate the development of frailty in at-risk older sarcopenic obese patients who are at risk for physical function limitations
- Presenting the 5 clinical studies of enobosarm in older patients and in patients with a cancer induced starvation-like state that provide a strong scientific rationale for the ongoing Phase 2b enobosarm + GLP-1 RA clinical study
- Providing supporting evidence that enobosarm in combination with a GLP-1 RA may potentially augment the fat reduction with higher quality total weight loss while preserving muscle and physical function
Additional information on the meeting can be found on the GLP-1 Based Therapeutics Summit website: https://glp-1-based-therapeutics.com/
About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial was 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 90 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®).The primary endpoint is difference in total lean body mass measured by DEXA, and the key secondary endpoints are differences in total body fat mass measured by DEXA and physical function as measured by stair climb test at 16 weeks. Topline clinical results from the trial are expected by the end of 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, 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. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.
About Sarcopenic Obesity
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 simulates a "starvation state" 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. 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 starvation-like state 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.
Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 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.