FDA Approves Veru's Phase 2b Trial of Enobosarm for Weight Loss-Related Muscle Preservation

Veru Inc., a biopharmaceutical firm specializing in the development of innovative treatments for weight loss, oncology, and ARDS, has received a significant boost with the FDA's clearance of its IND application. This clearance paves the way for a Phase 2b clinical trial of enobosarm, an oral selective androgen receptor modulator (SARM), which is being studied for its potential to maintain muscle mass and physical function while enhancing fat loss in elderly patients who are overweight or have sarcopenic obesity and are receiving GLP-1 RA drugs for weight loss.

GLP-1 RA drugs are known for their effectiveness in inducing weight loss, but they have been associated with muscle loss, which can be detrimental to metabolism, strength, and physical function. The Phase 2b trial, set to begin by April 2024, will assess the safety and efficacy of enobosarm in 90 elderly participants at risk of developing muscle atrophy and weakness. The primary focus of the trial will be on lean body mass, with total body fat mass as a key secondary endpoint after 16 weeks.

Upon completion of the initial phase, participants will enter an open-label extension trial where they will receive enobosarm monotherapy to evaluate its ability to reverse muscle loss and prevent fat and weight regain after discontinuing GLP-1 RA treatment. Results from this extension are expected in the second quarter of 2025.

Mitchell Steiner, M.D., Chairman, President, and CEO of Veru Inc., highlighted the importance of the FDA's clearance, stating that it will allow the company to assess enobosarm's potential as a combination treatment with GLP-1 drugs, particularly for elderly patients at high risk of muscle atrophy and frailty. The aim is to validate enobosarm's role in preserving muscle and physical function while promoting fat loss for a superior weight loss outcome.

Sarcopenic obesity is a prevalent condition, with the CDC reporting that over 40% of older adults in the U.S. are obese and could benefit from weight loss medication. A significant proportion of these patients suffer from sarcopenic obesity, which increases their risk when taking GLP-1 RA drugs due to their already low muscle mass.

Enobosarm has been studied in five clinical trials involving nearly 1000 participants, including older individuals with muscle wasting due to advanced cancer. The data from these trials indicate that enobosarm can increase muscle mass, improve physical function, and reduce fat mass. This provides a strong rationale for its potential use in combination with GLP-1 RA drugs to enhance fat reduction and total weight loss without muscle loss.

Enobosarm also boasts a robust safety profile, with 27 clinical trials involving over 1500 participants and a duration of treatment up to three years. It has been generally well-tolerated, which is crucial given the gastrointestinal side effects often associated with GLP-1 RA treatment.

Veru Inc. is committed to developing novel medicines for metabolic diseases, oncology, and ARDS. Its pipeline includes enobosarm for weight loss in combination with other drugs, and sabizabulin for the treatment of hospitalized patients with viral-induced ARDS. The company also markets the FDA-approved FC2 Female Condom® for protection against unplanned pregnancy and sexually transmitted infections.