Veru to Present at ADA's 84th Scientific Sessions

Veru Inc., a biopharmaceutical company, is set to present two significant presentations at the American Diabetes Association's 84th Scientific Sessions in Orlando, Florida, from June 21-24, 2024. Veru's focus is on developing innovative medicines for muscle preservation, weight loss, oncology, and viral-induced acute respiratory distress syndrome (ARDS).

The presentations are scheduled for June 22, 2024, from 12:30 PM to 01:30 PM Eastern Daylight Time at West Concourse A4-B2. The first presentation, "Pooled Safety Analysis of Enobosarm from Phase 2 and Phase 3 Placebo-Controlled Clinical Trials," will discuss the safety profile of Enobosarm. The second presentation, "Potential to Optimize Weight Loss with Enobosarm," will highlight a meta-analysis demonstrating Enobosarm's ability to preserve muscle while reducing fat.

Enobosarm is currently being evaluated in a Phase 2b clinical trial involving approximately 150 patients with sarcopenic obesity or overweight elderly patients who are also receiving semaglutide (Wegovy®). This trial aims to assess the safety and efficacy of two different doses of Enobosarm (3mg and 6mg) compared to a placebo. The primary endpoint is the total lean body mass, while secondary endpoints include total body fat mass and physical function measured by a stair climb test over 16 weeks. Participants will later enter an extension trial to determine if Enobosarm can maintain muscle and prevent fat gain after discontinuing GLP-1 RA therapy. Results from the main trial are expected by the end of 2024, and extension trial results by Q2 2025.

Sarcopenic obesity affects a significant percentage of older adults in the United States, with up to 34.4% of obese individuals over 60 years old also having sarcopenic obesity. These patients are at a heightened risk when using GLP-1 RA drugs for weight loss because of their already reduced muscle mass due to age-related muscle loss. This further muscle loss can lead to severe consequences such as poor balance, decreased mobility, and increased mortality.

Enobosarm (also known as ostarine, MK-2866, GTx-024, and VERU-024) has been studied in five clinical trials involving 968 older adults, including those with muscle wasting due to advanced cancer. These studies have shown that Enobosarm can increase muscle mass and improve physical function while reducing fat mass. The data suggest that combining Enobosarm with GLP-1 RA could enhance weight loss while preserving muscle mass.

Enobosarm has a robust safety profile, having been tested in 27 clinical trials with 1581 participants, some for up to three years. It has been well tolerated, with no significant increase in gastrointestinal side effects, which is noteworthy given the frequent gastrointestinal issues associated with GLP-1 RA treatments alone.

Veru Inc. is committed to developing novel treatments for metabolic diseases, oncology, and ARDS. Their current drug development program includes Enobosarm and Sabizabulin, another drug being developed for treating hospitalized patients with viral-induced ARDS. Veru also offers an FDA-approved commercial product, the FC2 Female Condom®, for dual protection against unplanned pregnancy and sexually transmitted infections.

Veru's announcement underscores its commitment to addressing critical health issues, and the upcoming presentations at the American Diabetes Association's Scientific Sessions will provide valuable insights into the potential benefits of Enobosarm for patients with sarcopenic obesity.

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