MIAMI, Fla., July 29, 2024 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late-stage clinical stage biopharmaceutical company focused on developing innovative medicines for high-quality weight loss, oncology and muscle sparing for viral-induced acute respiratory distress syndrome, today announced that it will participate in one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference on August 5, 2024.
About the Enobosarm Phase 2b Clinical Trial
The Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-ranging clinical trial is designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to preserve muscle and promote fat loss in approximately 150 sarcopenic obese or overweight older (≥60 years) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and key secondary endpoints are total body fat mass and physical function as measured by stair climbing test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, participants are expected to proceed to a blinded Phase 2b extension clinical trial, in which all patients will stop taking GLP-1 RAs but continue to take placebo, enobosarm 3 mg, or enobosarm 6 mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can preserve muscle and prevent fat and weight gain that occurs after cessation of GLP-1 RAs. Topline results from a separate blinded Phase 2b extension clinical trial are expected to be announced in Q2 2025.
Sarcopenic Obesity
According to the CDC, 41.5% of older adults in the United States are obese and could benefit from weight loss medications. Up to 34.4% of obese patients over 60 years of age have sarcopenic obesity. This large population of sarcopenic obese patients is at particular risk when taking GLP-1 medications for weight loss because they already have very low muscle mass due to age-related muscle loss. Further muscle loss while taking GLP-1 RA medications can lead to muscle weakness, poor balance, slower gait speed, impaired mobility, loss of independence, falls, fractures, and increased mortality, a condition that mimics age-related frailty. Because of the significant and rapid muscle loss during GLP-1 RA therapy for weight loss, GLP-1 RA medications may hasten the progression of frailty in older obese or overweight patients.
About Enobosarm
Enobosarm (also known as ostarine, MK-2866, GTx-024, VERU-024) is a novel selective androgen receptor modulator (SARM) that can be administered orally daily and has been studied to date in five clinical trials in 968 elderly normal men and postmenopausal women, as well as elderly patients with muscle wasting due to advanced cancer. Advanced cancer simulates a “starvation state” resulting in significant unintended loss or wasting of both muscle and fat mass, similar to that seen in patients taking GLP-1 RA drugs. Overall clinical data from the five clinical trials to date appears to demonstrate that enobosarm treatment produces dose-dependent increases in muscle mass and improvements in physical function, as well as significant dose-dependent losses in fat mass. Patient data from the five enobosarm clinical trials in both elderly patients and patients with cancer-related appetite suppression provide a strong clinical rationale for enobosarm. It is hoped that combining enobosarum with a GLP-1 RA may enhance fat loss and total weight loss while preserving muscle mass.
Importantly, enobosarm has a large safety database, including 27 clinical trials involving 1,581 men and women, some of which included patients treated for up to three years. In this large safety database, enobosarm was generally well tolerated with no increase in gastrointestinal side effects. This is important because GLP-1 RA treatment alone already has significant and frequent gastrointestinal side effects.
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 programs include two late-stage novel small molecules, enobosarm and sabizabrin.
Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) a Phase 2b clinical trial of enobosarm as a therapeutic to promote fat loss and prevent muscle loss in obese or overweight older patients with sarcopenia receiving GLP-1 RAs who are at risk of developing muscle atrophy and weakness, and (ii) the Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib as second-line treatment of androgen receptor-positive (AR+), estrogen receptor-positive (ER+), and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, subject to the availability of sufficient funding.
Sabizablin, a microtubule disrupting agent, is in development in Phase 3 clinical trials for the treatment of hospitalized patients with virally-induced ARDS. The Company does not intend to further develop Sabizablin for the treatment of virally-induced ARDS until it receives funding from a government grant, a pharmaceutical company partnership or other similar third-party external source.
We also have the FC2 Female Condom® (internal condom), an FDA-approved commercial product designed to provide dual protection against unwanted pregnancy and sexually transmitted diseases.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding whether the Phase 2b study of enobosarum described above will produce top-line data, whether and when patients will proceed to the extension study, the planned design, number of sites, timing, endpoints, patient population and number of patients of such study, whether such study will achieve any of its endpoints, whether enobosarum will promote weight loss or preserve muscle or meet an unmet need in obese patients, whether it will promote weight loss, whether our scientific advisors will make valuable contributions to our enobosarum program, and whether we will be successful in transforming into a late-stage biopharmaceutical company focused on obesity and oncology. Words such as “anticipate,” “believe,” “potential,” “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.The forward-looking statements in this press release are based on our current plans and strategies and reflect our current assessment of the risks and uncertainties associated with our business and are made as of the date of this press release. We undertake no obligation to update the forward-looking statements contained in this press release as a result of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions. Should such risks or uncertainties materialize, or should any of the assumptions prove incorrect, our actual results may differ materially from those expressed or implied in such statements.Factors that could cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the possibility that the development and clinical trial results of our product portfolio will fail or be insufficient to meet applicable regulatory standards or to warrant continued development, our ability to enroll a sufficient number of subjects in clinical trials and to enroll subjects according to planned timelines, our ability to fund planned clinical development and our other operations, the timing of and decisions by the FDA or other regulatory authorities, the possibility that our existing product, FC2, and any future products, if approved, will not be commercially successful, our ability to raise sufficient capital on acceptable terms if and when needed to fund development and operations, demand for, market acceptance of, and competition for, any of our products or product candidates, new or existing competitors with greater resources and capabilities, and the approval and/or introduction of new competing products. changes in regulatory practices or policies or government-driven healthcare reform initiatives, including pricing pressures and changes in coverage and reimbursement; risks associated with developing a proprietary direct-to-patient telehealth platform, including our inexperience in developing such platforms, potential regulatory complexities, development costs and market awareness and acceptance of any telehealth platform we develop; risks related to our ability to increase sales of FC2, which have declined significantly in recent periods due to consolidation in the telehealth industry and the bankruptcy of a large telehealth customer; our ability to protect and enforce our intellectual property; delays in government tenders or orders or shipments in our U.S. prescription business could cause significant fluctuations in our operating results from quarter to quarter and adversely affect our net revenue and gross margins; our dependence on international partners and spending levels of national governments, global donors and other public health organizations in the global public sector; concentration of accounts receivable with our largest customers and the collection of those accounts receivable; These risks and uncertainties may be due to factors including, but not limited to, labor disputes and strikes, labor shortages, raw material shortages, physical damage to our and third party facilities, product testing, potential disruptions to production at our and third party manufacturing facilities and/or our ability to timely supply products, constraints and interruptions in our production capacity, efficiency, supplies, including due to transportation delays or regulatory actions, the costs and other impacts of litigation, including product liability claims and securities litigation, our ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives, our ability to successfully integrate acquired businesses, technologies or products, and other risks detailed from time to time in our press releases, shareholder communications and filings with the Securities and Exchange Commission, including our Form 10-K for the year ended September 30, 2023, as amended by Form 10-K/A, and any subsequent Quarterly Reports on Form 10-Q. These documents are available under the “SEC Filings” section of our website at www.verupharma.com/investors.
* Wegovy® is a registered trademark of Novo Nordisk A/S.
Investor and Media Contacts:
Samuel Fish
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
