Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with GLP-1 Drugs for Weight Loss

MIAMI, FL, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the development of enobosarm for obesity.

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that result in significant weight loss. Unfortunately, up to 50% of the total weight loss comes from muscle which is problematic as muscle is necessary for metabolism, strength, and physical function. According to the CDC, 41.5% of older U.S. adults have obesity and could benefit from a weight loss medication. Up to 34.4% of these patients over the age of 60 have sarcopenic obesity which means patients are overweight or obese and also have age-related low muscle mass. Sarcopenic obese patients are potentially at the greatest risk for developing critically low amounts of muscle mass when taking a GLP-1 RA medication for the treatment of obesity. Patients with critically low muscle mass may experience muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality.

“We believe there is an urgent unmet medical need for a drug that when given in combination with GLP-1 RA therapy prevents the loss of muscle, while preferentially reducing fat in not only overweight or obese patients, but especially for sarcopenic obese or overweight elderly patients who are at-risk for developing muscle atrophy and muscle weakness leading to frailty,” stated Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “Today’s announcement is an important milestone for Veru and ultimately for the many patients who desire to avoid loss of muscle when taking a GLP-1 RA drug for weight loss.”

Planned Phase 2b Enobosarm for Obesity Clinical Trial
The Company plans to conduct a Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in approximately 90 randomized sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness. The primary endpoint of the Phase 2b clinical trial will be the change in lean body mass (muscle) from baseline to 3 months and key secondary endpoints will be the change from baseline to 3 months in total fat mass, insulin resistance, total body weight, and physical function measured by the stair climb test. The primary 3-month clinical data from the Phase 2b clinical trial is currently expected in calendar Q4 2024. The purpose of the Phase 2b clinical trial is to select the optimal dose of enobosarm in combination with a GLP-1 RA that best preserves muscle and reduces fat after 3 months of treatment to advance into a Phase 3 obesity or overweight clinical trial.

After completing the 3-month efficacy dose-finding portion of the Phase 2b clinical trial, participants will then continue into an open label extension trial where all patients will receive 6 mg of enobosarm for 3 months to determine the ability of enobosarm to rescue or reverse muscle loss and prevent fat and weight rebound after stopping a GLP-1 RA drug.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.

Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to Veru’s expectations regarding whether the FDA will accept the enobosarm IND, whether and when the planned phase 2b trial of enobosarm discussed above will commence, the planned design, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will meet any unmet need for obesity patients, and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of Veru Inc. (the Company) and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering and the Company’s expectations regarding the completion, timing and size of the proposed public offering and the use of proceeds therefrom. This list is not exhaustive and other risks are detailed in the Company’s periodic reports filed with the SEC, including the Company's Form 10-K for the year ended September 30, 2023.

Investor Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: [email protected]