Veru Announces Safety and Body Composition Data from Two Late-Breaker Presentations at the American Diabetes Association's 84th Scientific Sessions
Veru announced data from two late-breaking presentations at the American Diabetes Association's 84th Scientific Sessions held June 21-24, 2024, in Orlando, Florida. The presentations highlighted the safety and efficacy of enobosarm, a drug aimed at muscle preservation and high-quality weight loss. A pooled safety analysis (Poster #2067-LB) involving 1,027 subjects indicated that enobosarm was well-tolerated with similar adverse event rates to placebo, though elevated ALT levels were noted in 3.7% of enobosarm subjects versus 1.4% for placebo. A meta-analysis (Poster #2066-LB) involving 367 subjects showed enobosarm reduced fat mass by 6.26% and increased lean mass by 4.04% over placebo, suggesting its potential to improve weight loss quality.
- Enobosarm showed a reduction in fat mass by 6.26% and an increase in lean mass by 4.04% over placebo.
- The pooled analysis indicated that enobosarm was well-tolerated with adverse event rates similar to placebo.
- No increase in gastrointestinal side effects was observed with enobosarm treatment compared to placebo.
- 3.7% of enobosarm treated subjects experienced elevated ALT levels compared to 1.4% in the placebo group, although these elevations were transient and mild.
- The incidence of deep vein thrombosis was higher in the placebo group (3.3%) compared to the enobosarm group (1.0%).
Insights
Enobosarm Pooled Safety Analysis: The pooled analysis data demonstrates that Enobosarm was well tolerated across a diverse patient population, which includes older men, postmenopausal women and patients with advanced cancer. The absence of significant gastrointestinal side effects and the low occurrence of cardiovascular events are noteworthy. The mild, transient elevations in ALT levels suggest a relatively safe hepatic profile, which is pivotal for long-term medication adherence. It's important to highlight that such safety profiles, especially in a population prone to multiple comorbidities, can significantly bolster the market acceptance and competitive positioning of Enobosarm.
Body Composition and Weight Loss: The meta-analysis underscores Enobosarm's dual benefit of fat reduction and lean muscle preservation. These findings are particularly compelling in oncology, where muscle wasting (cachexia) is a profound challenge. By preserving lean muscle mass while reducing fat, Enobosarm could greatly enhance quality of life and potentially improve outcomes for cancer patients. Such a profile can differentiate Enobosarm from other treatments that might not offer muscle preservation. This could support regulatory approvals and guide clinical usage in oncology.
Market Implications: The positive safety and efficacy profiles of Enobosarm are likely to drive market traction, especially given the increasing prevalence of obesity and the global focus on high-quality weight loss solutions. The combined effect of muscle preservation and fat reduction positions the drug in a unique niche, making it attractive not only for the oncology sector but also for broader applications in obesity management. Moreover, the lower incidence of deep vein thrombosis in the Enobosarm group compared to the placebo group can significantly enhance its market appeal, particularly among clinicians concerned about thrombotic risks.
MIAMI, FL, June 24, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced data from two late-breaker presentations at the American Diabetes Association's 84th Scientific Sessions, which took place on June 21-24, 2024, in Orlando, Florida.
Late-Breaking Presentations:
Poster # 2067-LB: Pooled Safety Analysis of Enobosarm from Phase 2 and Phase 3 Placebo-Controlled Clinical Trials
Highlights from the presentation: In a pooled analysis of 1,027 older men, postmenopausal women, and older patients with advanced cancer, enobosarm was well tolerated with an adverse event profile comparable to the control patients. Notably, there was no increase in gastrointestinal side effects with enobosarm compared to placebo treatment.
Poster # 2066-LB: Potential to Optimize Weight Loss with Enobosarm—Meta-analysis of Body Composition from Three Randomized Clinical Trials Support the Ability of Enobosarm to Preserve Muscle while Reducing Fat
Highlights from the presentation: In meta-analysis of 367 older men, postmenopausal women, and older patients with muscle loss from advanced cancer (clinical studies 501, 502, and 504), enobosarm therapy resulted in reductions in fat mass (-
Additional information on the meeting can be found on the American Diabetes Association website: https://professional.diabetes.org/scientific-sessions
About the Enobosarm Phase 2b clinical trial
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 preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb 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 calendar year 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.
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 which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous 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 preserving muscle mass.
Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases 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.
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 ENABLAR-2 clinical trial of enobosarm and abemaciclib 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 whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program 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 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: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on 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 Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
FAQ
What safety data was presented for Veru's enobosarm at the ADA 84th Scientific Sessions?
How effective is enobosarm in preserving muscle and reducing fat according to the latest data?
What were the results of the meta-analysis on enobosarm presented at the ADA 84th Scientific Sessions?
Were there any significant adverse events associated with enobosarm in the recent trials?
How did enobosarm perform in terms of deep vein thrombosis incidence?
