Veru Inc. (VERU:NASDAQ), a biopharmaceutical company, has begun enrolling patients in its Phase 2b QUALITY trial, which will investigate the efficacy of enobosarm in combination with semaglutide for the treatment of sarcopenic obesity. This announcement follows the sale of the company's FC2 Female Condom business, a strategic move to focus on its biopharmaceutical pipeline.
The Phase 2b QUALITY trial is a multicenter, double-blind, placebo-controlled, randomized, dose-finding study. It is designed to evaluate the safety and efficacy of enobosarm at 3mg and 6mg doses in preserving muscle mass and augmenting fat loss in elderly patients (over 60 years of age) who are also receiving semaglutide. The trial has enrolled 168 patients.
Trial Design and Endpoints
The primary endpoint of the QUALITY trial is total lean body mass. Key secondary endpoints include total body fat mass and physical function, as measured by a stair climb test at 16 weeks. Topline clinical results are expected in January 2025. Following the initial phase, participants will continue in a blinded extension study for an additional 12 weeks, during which all patients will discontinue semaglutide but continue receiving either placebo, enobosarm 3mg, or enobosarm 6mg. This extension will assess enobosarm's ability to maintain muscle mass and prevent fat and weight gain after discontinuing the GLP-1 receptor agonist. Results from this extension study are anticipated in Q2 2025.
Strategic Shift and Financial Implications
Veru Inc. has sold its FC2 Female Condom business to clients of Riva Ridge Capital Management LP for US$18 million. According to a research note from H.C. Wainwright & Co. analysts Dr. Yi Chen and Dr. Raghuram Selvaraju, this transaction will provide non-dilutive capital for enobosarm's clinical development and reduce the company's headcount by approximately 90%, from 210 to 22 employees.
The sale is expected to generate approximately US$12.5 million in proceeds after deducting change of control premiums. Combined with Veru's September 2024 cash position of US$24.9 million, the pro forma cash position is estimated at US$37.4 million. The analysts suggest that additional capital may be needed within the next 12 months.
Sarcopenic Obesity Context
According to the CDC, 41.5% of older adults in the United States are obese, and up to 34.4% of obese individuals over 60 have sarcopenic obesity. This condition poses a significant risk when using GLP-1 receptor agonists for weight loss, as these patients already have reduced muscle mass due to age-related muscle loss. Further muscle loss from GLP-1 RA treatment can lead to muscle weakness, poor balance, decreased gait speed, mobility issues, falls, fractures, and increased mortality, resembling age-related frailty.
Enobosarm: A Selective Androgen Receptor Modulator (SARM)
Enobosarm, also known as ostarine, MK-2866, GTx-024, and VERU-024, is an oral SARM. It has been studied in five clinical trials involving 968 older men and postmenopausal women, as well as older patients with muscle wasting due to advanced cancer. Data suggest that enobosarm treatment leads to dose-dependent increases in muscle mass, improvements in physical function, and reductions in fat mass. The expectation is that enobosarm, combined with a GLP-1 RA, could augment fat reduction and total weight loss while preserving muscle mass.
Enobosarm has a large safety database, including 27 clinical trials involving 1581 participants, with some dosed for up to three years. It has generally been well-tolerated, with no increases in gastrointestinal side effects, which are already common with GLP-1 RA treatment alone.
