Enobosarm

MIAMI, FL, Nov. 26, 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 that the Company will present at the at the 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders, taking place December 6-8, 2024, in Washington, DC. Presentation Name: The use of muscle selective anabolics to make GLP-1 RA weight loss drugs more effective and preciseDate: Friday, December 6th, 2024Start and end time: 4:15 PM - 5:30 PM Eastern Standard TimeLocation: Washington DC, USA Additional information on the meeting can be found on the following website: https://society-scwd.org/annual-conference/?v=0b3b97fa6688 About the Enobosarm Phase 2b QUALITY clinical trialThe fully enrolled Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding QUALITY clinical trial is evaluating the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in 168 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. Topline clinical results from the trial are expected in January of 2025. After completing the efficacy dose-finding portion of the Phase 2b QUALITY 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 ObesityAccording to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients. About EnobosarmEnobosarm (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 causes the loss of appetite 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 appetite suppression 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. 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 QUALITY 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 StatementsThis 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 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; the Company’s failure to timely file certain reports in February 2024 may impair its ability to raise capital under the Company’s current effective shelf registration statement on Form S-3 or under a new registration statement; 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 FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com

SAN ANTONIO — It took decades to get to the GLP-1 breakthrough in obesity treatment. Now, the biopharma industry is clamoring over the field’s next frontier: staving off the losses in muscle or lean mass that have been seen with existing drugs. Muscle preservation has become an increasing focus as leaders gathered in Texas this week for ObesityWeek, one of the main medical research conferences centered around the chronic disease. “If you look at the field of incretins — whether it’s single agonists, dual agonists, triple agonists — in my mind, I don’t think we need more weight loss,” Scholar Rock CSO Mo Qatanani told Endpoints News on the sidelines of the confab. “As far as weight loss, I think we’re good; there’s a lot of advancement there,” he added. “I think the next step to look at is this healthier weight loss that you can maintain, that’s durable.” Muscle preservation is key for a variety of health reasons, including implications on metabolism and the overall endocrine system, said Volkan Granit, a Biohaven medical director and neurologist. Retaining muscle mass is particularly relevant for elderly patients, he said, noting the risk of sarcopenia. Biohaven and Scholar Rock are developing myostatin-focused drugs for both spinal muscular atrophy and obesity. If muscle is retained, it could also help extend the durability of obesity drugs and lead to more fat loss, leaders in the field said. Patients on GLP-1s are losing more muscle in a year than they normally would in 10 years, Veru CEO Mitchell Steiner said. The Miami-based biotech is testing an oral selective androgen receptor modulator called enobosarm in a Phase 2b trial in combination with Wegovy. The company will have 16-week data in January 2025, and it plans to run two Phase 3 studies in obesity, for which a partner “would be wonderful,” Steiner said. The GLP-1s aren’t alone in affecting muscle loss. Many types of weight loss approaches, like gastric bypass surgery and caloric restriction, also impair lean mass, according to leaders in the field. “The rule of thumb is you want to keep it 70/30: 70% loss of fat, 30% loss of lean body mass,” said Nikhil Dhurandhar, chair of the nutritional sciences department at Texas Tech University and editor-in-chief of the International Journal of Obesity . Studies have shown about 25% to 55% of lean body mass loss for the GLP-1 class, Dhurandhar said, describing it as a “big deal.” At this point, though, he said he’s a proponent of adding walking exercises and “adequate protein diet” interventions on top of GLP-1 treatment rather than additional obesity medicines. Eli Lilly and Novo Nordisk, the GLP-1 behemoths, are among those also developing medicines thought to have less of an impact on muscle loss. “We’re all waiting for the big gorilla in the room to materialize, which is the ongoing, now Lilly-sponsored trial with bimagrumab plus semaglutide,” SixPeaks Bio CEO Philip Just Larsen said. AstraZeneca has the option to buy his preclinical biotech, which is developing activin-focused drugs for what it calls “healthy weight loss.” Bimagrumab aims to block both activin and myostatin signaling. The drug was originally at Novartis, then swooped up by Versanis Bio, which Lilly bought for up to $1.9 billion last year. Versanis was testing bimagrumab in combination with semaglutide, but Lilly has yet to report those results. Last month, the Indianapolis-based pharma started a new trial testing the injectable in combination with tirzepatide. Nadia Ahmad, an associate VP who leads Lilly’s Phase 3 obesity trials, said it has to be thought of in a broader body composition lens. “With potential investigational medications like bimagrumab, it’s about the fat mass as much as it is about muscle preservation,” Ahmad said on the sidelines of ObesityWeek, “and being able to really hone in on efficacy from a fat mass reduction standpoint, because that’s the crux of what we’re trying to treat here.” Drug developers are also looking at the pancreatic hormone amylin as a potential way of honing in on selective fat loss. Zealand Pharma thinks its petrelintide asset, weeks away from entering Phase 2, could be a “ foundational ,” first-line approach that could rid the need for GLP-1 for some patients. Novo also has an amylin program, combined with semaglutide, that will have key Phase 3 data by year’s end. AstraZeneca also highlighted the potential for amylin earlier this week, as did Structure Therapeutics.