Veru to Present at 2024 Jefferies Global Healthcare Conference

Veru Inc., a biopharmaceutical company in its late clinical stages, is making strides in developing innovative treatments aimed at preserving muscle mass during weight loss, oncology, and addressing viral-induced acute respiratory distress syndrome (ARDS). On May 22, 2024, the company announced that its Chairman, President, and CEO, Mitchell Steiner, M.D., will provide an update on their Phase 2b clinical program of enobosarm at the Jefferies Global Healthcare Conference on June 5, 2024.

The Phase 2b clinical trial being highlighted aims to evaluate the safety and effectiveness of enobosarm, specifically in combination with GLP-1 drugs like semaglutide (Wegovy®), which are used for weight loss. The trial is randomized, double-blind, placebo-controlled, and dose-finding, involving 90 patients aged over 60 who have sarcopenic obesity or are overweight. The primary goal of the trial is to observe the differences in total lean body mass among participants, with secondary goals including changes in total body fat mass and physical function, measured by a stair climb test over a 16-week period. The trial is actively enrolling patients across up to 15 clinical sites in the United States, and topline results are anticipated by the end of 2024.

Following the initial 16-week period, participants are expected to continue in a blinded Phase 2b extension trial, where the use of GLP-1 drugs will be discontinued, but patients will continue receiving either a placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. This extension aims to evaluate whether enobosarm can help maintain muscle mass and prevent fat and weight gain after stopping GLP-1 drugs. The results of this extension study are expected in the second quarter of 2025.

Sarcopenic obesity is a condition affecting a significant portion of the elderly population, particularly those over 60, who lose muscle mass due to aging and are also obese. This condition makes them especially vulnerable to further muscle loss when using GLP-1 drugs for weight loss, potentially leading to frailty, poor balance, decreased mobility, and higher mortality rates.

Enobosarm is a selective androgen receptor modulator (SARM) that has been previously studied in clinical trials involving 968 older individuals, including those with muscle wasting due to advanced cancer. These trials have shown that enobosarm can increase muscle mass and improve physical function while also reducing fat mass, providing a strong clinical rationale for its use in combination with GLP-1 drugs. Enobosarm boasts a large safety database from 27 clinical trials involving 1581 participants, demonstrating its tolerance and minimal gastrointestinal side effects compared to GLP-1 drugs alone.

Veru Inc. is focused on developing novel treatments for metabolic diseases, oncology, and ARDS. Their drug development pipeline includes enobosarm and sabizabulin. Enobosarm is being developed for two primary indications: augmenting fat loss and preventing muscle loss in sarcopenic obese or overweight elderly patients on GLP-1 drugs, and a Phase 3 trial for treating certain types of metastatic breast cancer, contingent on funding. Sabizabulin is being developed as a treatment for hospitalized patients with viral-induced ARDS, though further development hinges on obtaining external funding.

In addition to its drug development efforts, Veru Inc. also markets the FC2 Female Condom® for dual protection against unintended pregnancy and sexually transmitted infections, showcasing the company's commitment to diverse, impactful healthcare solutions.