Veru Announces FDA Clearance of IND Application to Initiate Phase 2b Clinical Trial with Enobosarm to Treat Muscle Loss Associated with Weight Loss Drugs
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The FDA's IND clearance for Veru Inc.'s Phase 2b clinical trial of enobosarm in combination with GLP-1 drugs is a significant step towards addressing the issue of muscle loss in weight loss treatments. The current GLP-1 drugs, while effective for weight loss, have been shown to result in muscle loss, which can be detrimental to overall health, especially in the elderly. Enobosarm, a selective androgen receptor modulator, aims to preserve muscle mass during the weight loss process, potentially leading to a more desirable outcome for patients.
From a medical research perspective, this trial is noteworthy as it targets a specific patient population—sarcopenic obese or overweight elderly individuals. The focus on lean body mass as the primary endpoint, with total body fat mass as a key secondary endpoint, aligns with current trends in weight management therapies that emphasize the importance of preserving muscle integrity. The results of this trial could influence future treatment protocols and standards for weight loss therapies, particularly in aging populations.
The initiation of the Phase 2b clinical trial and the potential commercialization of enobosarm could have substantial financial implications for Veru Inc. The market for weight loss drugs is already competitive, but Veru's focus on a combination therapy that preserves muscle mass could differentiate it from existing treatments. If the trial results are positive and lead to FDA approval, the company could capture a significant share of the market, especially among elderly patients with sarcopenic obesity.
Investors should monitor the progression of the trial and be aware of the risks involved in clinical development. The pharmaceutical industry is known for its high rate of clinical trial failures, which can impact a company's stock price and financial stability. However, a successful trial outcome could lead to partnerships, licensing deals, or even acquisition interest, providing potential upside for shareholders. The expected timeline for trial commencement and results will also be key factors in assessing the short-term and long-term investment potential of Veru Inc.
The progression of enobosarm through clinical trials and potential FDA approval may have broader economic implications beyond just the financial performance of Veru Inc. The healthcare costs associated with obesity and related conditions such as muscle atrophy are substantial. A treatment that effectively promotes fat loss while preserving muscle could reduce long-term healthcare expenditures by mitigating complications associated with muscle loss and frailty in the elderly.
Additionally, the development of such treatments can spur innovation and investment in the biopharmaceutical sector, potentially leading to job creation and economic growth. The societal benefits of improved treatments for obesity and sarcopenia could also translate into increased productivity and reduced disability-related costs, contributing positively to the economy.
FDA IND clearance is an important development milestone in advancing enobosarm in combination with GLP-1 drugs for potentially higher quality weight loss than has been shown with GLP-1 drug alone
Randomized Phase 2b clinical trial aims to show enobosarm preserves muscle and physical function while augmenting fat loss in sarcopenic obese or overweight elderly patients on GLP-1 drug for weight loss
Phase 2b clinical trial is expected to initiate by April 2024
Phase 2b clinical trial final topline results are anticipated by year-end
MIAMI, FL, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for potentially higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its Phase 2b clinical study to evaluate enobosarm, an oral novel selective androgen receptor modulator (SARM), to preserve muscle mass and physical function and further increase fat loss in patients receiving a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug for potentially higher quality weight loss.
GLP-1 RA drugs are very effective drugs that result in significant weight loss. Unfortunately, studies have shown that up to
Planned Phase 2b enobosarm clinical trial design for potentially higher quality weight loss
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 90 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 is lean body mass (muscle), and the key secondary endpoint is total body fat mass at 16 weeks. The clinical study is expected to begin by April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024.
After completing the 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 monotherapy for 12 weeks to determine the ability of enobosarm to rescue, or reverse muscle loss and prevent fat and weight rebound after stopping a GLP-1 RA. The results of the separate Phase 2b open label extension clinical study is expected in calendar Q2 2025.
“FDA clearance of our IND will allow us to evaluate enobosarm as a combination treatment with GLP-1 drugs to prevent the loss of muscle, while preferentially reducing fat in not only overweight or obese patients, but especially for the large subpopulation of 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. “We look forward to starting the Phase 2 clinical study to further validate enobosarm’s ability to preserve muscle and physical function while augmenting fat loss to provide for a potentially higher quality weight loss.”
About Sarcopenic Obesity
According to the CDC,
About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass similar to what is observed with GLP-1 RA treatment. The totality of the clinical data from these five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while avoiding muscle loss.
In addition, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women dosed with duration of treatment in some patients for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increase in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.
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.
Metabolic pipeline: Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), an oral daily novel selective androgen receptor modulator (SARM), is being developed as a treatment in combination with weight loss drugs to augment fat loss and avoid muscle loss in overweight or obese patients for chronic weight management. Initially, enobosarm will be developed in a Phase 2b clinical study to address the large subpopulation of sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness leading to physical function mobility disability and frailty.
Oncology pipeline: Phase 3 clinical development of enobosarm for 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.
Infectious disease pipeline: 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 and when the planned phase 2b trial of enobosarm discussed above will commence by April 2024, the planned design, timing, endpoints, patient population and patient size of such Phase 2b trial and whether such trial will successfully meet any of its endpoints; whether enobosarm will be shown to preserve muscle and physical function while augmenting fat loss in the specified patient populations; whether the Phase 2b data will be available by the end of 2024; whether the data will warrant continued study and whether and when the clinical trial participants will continue into an open-label extension study and when those results will be available; whether enobosarm will meet any unmet need for obesity patients; the planned timing, design, endpoints, patient population and expected funding of the Company’s breast cancer and infectious disease pipeline; 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 and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
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