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Yahoo
28-05-2025
- Business
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Veru Reports Positive Safety Results from Phase 2b QUALITY Study: Enobosarm Added to Semaglutide Led to Greater Fat Loss, Preservation of Muscle, and Fewer Gastrointestinal Side Effects Compared to Semaglutide Alone
--Phase 2b QUALITY clinical study topline safety data shows that the enobosarm + semaglutide combination had a positive safety profile compared to semaglutide alone-- --Based on Phase 2b QUALITY trial efficacy and safety data, enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program----Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects (Diarrhea, Nausea, and GERD) compared to semaglutide alone-- --Enobosarm 3mg added to semaglutide resulted in the highly selective loss of fat mass, accounting for 99% of the total weight lost, while preserving lean mass-- --With this positive Phase 2b QUALITY study, Veru has requested an End of Phase 2 meeting with FDA to provide regulatory clarity on the Phase 3 clinical program-- --The topline efficacy and safety data for the Phase 2b extension maintenance study to assess whether enobosarm monotherapy prevents the fat and weight regain following discontinuation of semaglutide are expected in the second quarter-- MIAMI, FL, May 28, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced positive topline safety results from the Phase 2b QUALITY clinical study, a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial, designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to enhance fat loss and to prevent muscle loss in older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management. Positive Topline Safety Results for the Phase 2b QUALITY Clinical Trial Adverse events (AEs) and adverse events of special Interest (see table below).In the Phase 2b QUALITY clinical trial, enobosarm and semaglutide GLP-1 RA combination had a positive safety profile. There were no increases in gastrointestinal side effects, no evidence of drug-induced liver injury (as defined by Hy's law), and no increases in obstructive sleep apnea at any dose of enobosarm compared to placebo (semaglutide alone). There were no AEs of increases in prostate specific antigen in men. There were no AEs related to masculinization in women. There were no reports of suicidal ideation observed (Columbia-Suicide Severity Rating Scale). No treatment related serious adverse events (SAEs) were observed in the QUALITY study. There were 4 non-treatment related SAEs equally distributed between the treatment groups. At the proposed Phase 3 clinical program dose of enobosarm 3mg, one subject experienced an adverse event of transient, mild increase in alanine aminotransferase (ALT), which returned to baseline while remaining on enobosarm. There were no accompanying increases in aspartate aminotransferase (AST), alkaline phosphatase or total bilirubin. The enobosarm 3mg + semaglutide group had the added benefit of fewer AEs reported for certain gastrointestinal side effects (Diarrhea, Nausea, and Gastroesophageal Reflux Disease) compared to placebo + semaglutide. 'The safety results from the Phase 2b study are positive and suggest that the addition of enobosarm to semaglutide treatment doesn't worsen, and in some cases appears to improve gastrointestinal side effects', said Louis J. Aronne, MD, an obesity expert, past president of the Obesity Society and a scientific advisor and consultant to Veru. Topline Phase 2b QUALITY clinical trial safety summary: Adverse Events1 and Adverse Events of Special Interest Placebo+Semaglutiden=56 Enobosarm 3mg+Semaglutiden=56 Enobosarm 6mg+Semaglutiden=56 Nausea 11 (20%) 6 (11%) 8 (14%) Gastroesophageal Reflux Disease (GERD) 7 (13%) 3 (5%) 0 (0%) Diarrhea 4 (7%) 1 (2%) 7 (13%) Vomiting 2 (4%) 1 (2%) 4 (7%) Constipation 8 (14%) 7 (13%) 6 (11%) Alanine aminotransferase (ALT) increased 0 (0%) 1 (2%)2 6 (11%)3 Aspartate aminotransferase (AST) increased 0 (0%) 0 (0%) 1 (2%)3 Obstructive sleep apnea syndrome 9 (16%) 10 (18%) 11 (20%) Upper respiratory tract infection 1 (2%) 1 (2%) 4 (7%) Headache 2 (4%) 4 (7%) 1 (2%) Fatigue 2 (4%) 0 (0%) 4 (7%) 1 Adverse events (at least 4 subjects in any dose group) from Day 1 to Day 1122 Graded as mild in severity, levels returned to below baseline while on drug, no associated increase in alkaline phosphatase or total bilirubin3 All graded as mild in severity, all returned to or toward baseline/upper limit of normal, no associated increases in alkaline phosphatase or total bilirubin 'We previously shared positive results from the Phase 2b QUALITY study, indicating that enobosarm can selectively enhance fat loss while preserving lean mass and physical function in older patients using semaglutide for weight loss. Today, we announced that the topline safety data from the Phase 2b QUALITY clinical study confirms that enobosarm has a positive safety profile with the added benefit of reducing certain gastrointestinal side effects that patients commonly experience with semaglutide and other GLP-1 receptor agonists. Based on these efficacy and safety results, the enobosarm 3mg dose has been selected to advance into our proposed Phase 3 study,' said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. 'We have submitted a request for an End of Phase 2 meeting with FDA, which we anticipate will take place in the third quarter of calendar year 2025. The meeting is expected to provide regulatory clarity on the design of our planned Phase 3 clinical program. Further, we are expecting the topline efficacy and safety results for the Phase 2b extension maintenance study this quarter, which will show us whether enobosarm monotherapy can stop the fat and weight regain that generally happens when patients discontinue GLP-1 receptor agonist treatment. Finally, we look forward to reporting the full Phase 2b QUALITY and extension clinical trial efficacy and safety data at future leading scientific conferences and in prestigious publications.' Positive Topline Efficacy Results for the Phase 2b QUALITY Clinical Study: Enobosarm in Combination with GLP-1 RA Drugs Makes Weight Reduction More Tissue Selective for Fat Loss While Preserving Lean Mass and Physical Function In January 2025, the Company announced positive topline results from the Phase 2b QUALITY clinical study, which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial 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 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management. Topline Efficacy Results Topline Primary Endpoint – Percent Change in Total Lean MassIn the topline efficacy analysis, the trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks in total lean mass (71% relative reduction in lean mass loss, p=0.002). Notably, the enobosarm 3mg + semaglutide was the best dose with a 99.1% mean relative reduction in loss of lean mass (p <0.001). The enobosarm 6mg + semaglutide dose did not provide any additional benefit over the 3mg dose in preserving lean mass. Topline Secondary Endpoints:Total Fat Mass Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the enobosarm 6mg dose having a 46% greater relative loss of fat mass compared to placebo + semaglutide group at 16 weeks (p=0.014). Weight Loss and Tissue Composition of Weight Loss Although mean weight loss by DEXA was similar in the enobosarm + semaglutide groups compared to semaglutide alone at 16 weeks, the composition of total weight loss shifted toward greater and more selective fat loss with enobosarm treatment: In the placebo + semaglutide group, the median percentage of total body weight loss due to lean mass was 32%, and estimated fat loss was 68%. In the enobosarm 3mg + semaglutide group, the median percentage of total body weight loss due to lean mass was 0.9%, and estimated fat loss was 99.1%. Physical Function Measured by the Stair Climb Test The Stair Climb Test is used to measure physical function and is an activity of daily living that measures functional muscle strength, balance and agility. Decline in Stair Climb Test performance in older adults is predictive of increased risk for mobility disabilities, gait difficulties, falls, bone fractures, hospitalizations, and mortality. As a reference point, stair climb power declines by -1.38% per year with aging according to Van Roie E, et al. PLOS ONE.14:e0210653, Climb Test Results:A responder analysis was conducted using a greater than 10% decline in stair climb power at 16 weeks as the cutoff, which corresponds to approximately 7.5 years' worth of stair climb power loss due to natural aging. In the placebo + semaglutide group, 42.6% of patients experienced at least a 10% decline in stair climb power at 16 weeks. In the enobosarm 3mg + semaglutide group, only 16% of patients had at least a 10% decline in stair climb power at 16 weeks, representing a 62.4% relative reduction of patients with a ≥10% decline in power compared to the placebo + semaglutide group (p=0.0066). In the enobosarm 6mg + semaglutide group, only 22.5% of patients had at least a 10% decline in stair climb power at 16 weeks, representing a 46.2% relative reduction of patients with a ≥10% decline on power compared to the placebo + semaglutide group (p=0.0505). Topline Efficacy Results ConclusionThe Phase 2b QUALITY clinical trial is the first human study to show that older patients who are overweight or have obesity and receiving semaglutide, a GLP-1 receptor agonist, are at higher risk for accelerated loss of lean mass and associated physical function decline. Enobosarm added to semaglutide enhanced loss of fat, with 99% of the total weight loss attributable to fat. In addition, enobosarm treatment preserved lean muscle mass, which translated into an improvement in physical function as measured by the Stair Climb Test compared to semaglutide alone. Enobosarm represents a novel drug that improves body composition by driving a more selective and greater loss of adiposity (fat mass) and preserving both lean mass and physical function in patients receiving semaglutide for chronic weight management. Phase 2b Extension Maintenance StudyAfter completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, participants continued into a Phase 2b extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy in a blinded fashion for 12 weeks. The Phase 2b extension clinical trial is evaluating whether enobosarm, by preserving muscle mass, also prevents the fat regain that generally occurs after stopping a GLP-1 RA. The topline efficacy and safety results for the Phase 2b extension clinical study are expected this quarter. Regulatory Next StepsAs the Phase 2b QUALITY clinical trial is a positive study, we have requested an End of Phase 2 meeting with the FDA. During the preIND FDA meeting, FDA provided general comments about a regulatory path forward for enobosarm as a drug that improves body composition during weight loss including input on the Phase 3 clinical program design. As a path forward, we plan to propose a Phase 3 clinical program that is similar to the positive Phase 2b QUALITY clinical trial. The proposed Phase 3 clinical trial design is a double-blind, placebo-controlled study in older patients (≥60 years of age) who have obesity or who are overweight and who are eligible for treatment with GLP-1 RA. The GLP-1 RA may be either Wegovy® (semaglutide) and/or Zepbound® (tirzepatide). Patients will be randomized to oral daily enobosarm or matching placebo. All subjects will start and receive GLP-1 RA during the study. The proposed primary objective will be the effect of enobosarm on physical function measured by the Stair Climb Test at 24 weeks. Proposed key secondary objectives will be to assess the effect of enobosarm on total lean mass, total fat mass, insulin resistance, and hemoglobin A1c at 24 weeks. After the Phase 3 clinical trial ends at 24 weeks of treatment, the plan is to continue to measure total lean mass, total body weight, stair climb power physical function, total fat mass, bone mineral density, insulin resistance, and hemoglobin A1c up to 68 weeks to capture the longer-term benefits of enobosarm improvements on body composition for greater loss of adiposity or fat, weight reduction, and preservation of both lean mass and bone. Novel Modified Release Oral Enobosarm Formulation is on Track to be Available for Phase 3 Clinical Studies and CommercializationVeru is currently developing a novel, patentable, modified release oral formulation for enobosarm. The actual formulation, pharmacokinetic release profile(s), and method of manufacturing will be the subjects of future patent applications. If issued, the expiry for the new modified release oral enobosarm formulation patent is expected to be 2045. The new enobosarm formulation has completed animal trials and is anticipated to be in Phase 1 bioavailability clinical trials during the first half of calendar 2025. The expectation is that this novel modified release oral enobosarm formulation will be available for the Phase 3 clinical studies and for commercialization. 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 full data set, including safety data, from the Phase 2b QUALITY study of enobosarm discussed above will be made available and whether that data will align with disclosed topline results or change any of the conclusions drawn from the topline data; whether and when the Company will present the full data from the Phase 2b QUALITY study and in what forum; whether and when the Company will present data from the extension maintenance study and whether such extension study will successfully meet any of its endpoints; whether and when the Company will have an end-of-Phase-2 meeting with FDA and the results of any such meeting; whether the results of the Phase 2b QUALITY study of enobosarm will be replicated to the same or any degree in any future Phase 3 studies; the expected costs, timing, patient population, design, endpoints and results of the planned Phase 3 studies of enobosarm as a body composition drug or any other Phase 3 studies; whether the Company and FDA will align on the Phase 3 program for enobosarm as a body composition drug and whether any such program will be able to be funded by the Company; whether the modified-released formation of enobosarm will be developed successfully and whether such formulation will have the same effectiveness as the current formulation, and whether and when such modified-release formulation will be available for any planned or future clinical studies; whether and when any patents will actually issue regarding such modified-release formulation and what any expiration dates of any such patents might be; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned Phase 3 study or other Phase 3 studies; whether FDA will require more than one Phase 3 study for enobosarm as a body composition drug; 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 in any planned or other Phase 3 studies or if approved, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will have a greater loss of adiposity or greater weight loss than with semaglutide alone; and whether and when enobosarm will be approved by the FDA as a body composition drug. 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 Company's ability to reach agreement with FDA on study design requirements for the Company's planned clinical studies, including for the Phase 3 program for enobosarm as a body composition drug and the number of Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability 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 potential for disruptions at the FDA or other government agencies to negatively affect our business; any products of the Company, 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; the Company's ability to protect and enforce its intellectual property; 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, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the 'SEC Filings' section of our website at Wegovy® is a registered trademark of Novo Nordisk A/ is a registered trademark of Eli Lilly and Company. Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
30-04-2025
- Health
- Yahoo
NodThera's Oral NLRP3 Inhibitor NT-0796 Enhances and Sustains Weight Loss in Combination with GLP-1
Philadelphia, PA, April 30, 2025 - NodThera, a leading clinical-stage biotech delivering a paradigm shift in the treatment of chronic inflammatory diseases through selective modulation of the NLRP3 inflammasome, today announces the publication of preclinical data demonstrating the potential of its clinical-stage, oral NLRP3 inflammasome inhibitor NT-0796 to augment existing GLP-1 receptor agonist (GLP-1RA) obesity therapies to deliver enhanced weight loss and sustained weight management. These data, published in the research journal Obesity, show that combined dosing of NodThera's NT-0796 with semaglutide (Wegovy®) drove greater weight loss than either monotherapy in an animal model of obesity. Treatment with the fully brain-penetrating NLRP3 inflammasome inhibitor also sharply limited weight regain following the cessation of semaglutide therapy and reduced multiple cardiovascular, inflammatory and metabolic biomarkers. Despite the significant achievements of GLP-1RAs in the management of obesity, their use is impacted by challenges related to tolerability and the weight regain following discontinuation of treatment. NodThera is pioneering a new approach to obesity treatment built on the growing understanding of the impact of chronic inflammation on the body and its underlying role in the complex cycle of weight regulation. These new data build on NodThera's earlier preclinical and clinical work and support the potential of central NLRP3 inhibition to reset multiple dysregulated cardiometabolic pathways, restoring the body's natural metabolic balance and enabling sustained and healthy weight loss. Enhanced weight loss effects of NT-0796 and semaglutide in combinationIn NodThera's latest publication, the researchers show that weight loss induced by a combination of NT-0796 and semaglutide was nearly two-fold higher at 23% over 28 days compared to semaglutide monotherapy in a high fat diet murine obesity model. Weight loss was further enhanced on the combination therapy when animals were switched for a further 28 days to a polyunsaturated fatty acid diet, intended to be more reflective of a typical human diet. Animals receiving the combination therapy experienced continued weight loss, completely reversing their obese state, with a weight loss of >30% to achieve a weight comparable to animals fed a standard control diet. Hypothalamic (brain) inflammation was also reversed among animals maintained on the combination therapy. Prevention of weight regain post-semaglutide treatment In animals who were switched to NT-0796 monotherapy, following treatment with either semaglutide alone or the NT-0796 and semaglutide combination, the degree of weight regain was highly reduced compared to animals who stopped all therapy. Potential of NLRP3 inhibition to enable a healthy weight lossDEXA scans determined that combination therapy increased fat mass loss whilst preserving lean mass. Calorie intake was also further reduced in animals on the combination therapy, but the degree of fat mass loss observed suggests additional mechanisms, such as enhanced energy expenditure, may contribute. This supports a model consistent with the observed reduction in both peripheral and hypothalamic (brain) inflammation as a druggable mechanism in obesity pathogenesis. Daniel Swisher, Chief Executive Officer of NodThera, commented: 'These data further reinforce our belief in the potential of our brain-targeting NLRP3 inflammasome inhibitor to deliver a step change in the management of obesity. While the efficacy of existing treatments is not in doubt, there are many limitations and challenges to their real-world use by patients. The opportunity to provide patients with a highly effective oral therapy with a well-tolerated safety profile and without titration complexities is compelling and supported by our growing body of evidence indicating NT-0796's potential as monotherapy and in combination to improve the efficacy and tolerability of existing treatments, or even as a follow-on therapy to sustain weight loss.' Alan Watt, President and Chief Scientific Officer of NodThera, added: 'By harnessing both peripheral and central NLRP3 inhibition to correct multiple dysregulated pathways in the brain and throughout the body we have the potential to bring profound cardiometabolic benefits to patients, establishing an enhanced treatment approach to weight management that would enable sustained and healthier weight loss.' NodThera is currently preparing to initiate a robust Phase 2 obesity study of NT-0796, expected in 2Q 2025. Details about the trial's design will be communicated upon initiation of dosing. For more information about NodThera please contact: NodTheraTel: +44 (0) 1223 608130Email: info@ ICR Healthcare Amber Fennell, David Daley Tel: +44 (0)20 3709 5700Email: nodthera@ About NodTheraNodThera is a leading clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases. Led by an experienced management team, NodThera is combining a deep understanding of NLRP3 inhibition, pharmaceutical neuroscience expertise and precision chemistry. Its two lead clinical candidates are oral, small molecule NLRP3 inflammasome inhibitors, which have demonstrated differentiated, potentially best-in-class clinical profiles with significant anti-inflammatory effects and high brain penetration, offering distinct opportunities to treat multiple indications. The Company is backed by top-tier investors including 5AM Ventures, Blue Owl Capital, Epidarex Capital, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera is headquartered in Philadelphia, Pennsylvania, with additional operations in Cambridge, UK. Learn more at or follow the Company on in to access your portfolio
Yahoo
14-04-2025
- Business
- Yahoo
Skye Bioscience to Conduct Meetings at Piper Sandler Conference
SAN DIEGO, April 14, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) ('Skye'), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that its executive team will be available for 1x1 meetings at the Piper Sandler Spring Biopharma Symposium on April 17th in Boston, MA. About Skye Bioscience Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial ( NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: Connect with us on X and LinkedIn. CONTACTS Investor Relationsir@ 410-0266 LifeSci Advisors, Mike Moyermmoyer@ 308-4306 Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@ 234-3889 FORWARD LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, forward-looking statements can be identified by terminology including 'anticipated,' 'plans,' 'goal,' 'focus,' 'aims,' 'intends,' 'believes,' 'can,' 'could,' 'challenge,' 'predictable,' 'will,' 'would,' 'may' or the negative of these terms or other comparable terminology. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company's periodic filings with the Securities and Exchange Commission, including in the 'Risk Factors' section of Skye's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking in to access your portfolio
Yahoo
06-02-2025
- Business
- Yahoo
Veru to Report Fiscal 2025 First Quarter Financial Results on February 13, 2025
MIAMI, FL, Feb. 06, 2025 (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 it will host a conference call and audio webcast on Thursday, February 13, 2025, at 8:00 a.m. ET to discuss its fiscal 2025 first quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company's website at To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company's website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international), passcode 3764668, for one week. About the Enobosarm Phase 2b QUALITY Clinical TrialThe fully enrolled Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding QUALITY clinical trial evaluated 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 was total lean body mass, and the key secondary endpoints were total body fat mass and physical function as measured by stair climb test at 16 weeks. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, participants continued in blinded fashion into a Phase 2b extension clinical trial where all patients stopped receiving a GLP-1 RA, but continued 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 the second calendar quarter of 2025. Positive Topline Phase 2b QUALITY Clinical Trial DataOn January 27, 2025, the Company reported positive topline clinical results from the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial. In the topline efficacy analysis, the trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in the preservation of total lean body mass in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks (71% relative reduction in lean mass loss, p=0.002). The enobosarm 3mg + semaglutide was the best dose with a >99% mean relative reduction in loss of lean mass (p <0.001). Enobosarm 6mg + semaglutide dose was not better than the Enobosarm 3mg + semaglutide dose on lean mass. Secondary endpoints: Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the 6mg enobosarm dose having a 46% greater relative loss of fat mass compared to placebo + semaglutide group at 16 weeks (p=0.014). Although enobosarm + semaglutide significantly preserved lean mass, the additional loss of fat mass caused by enobosarm treatment was able to replace the lean mass preserved to allow a similar net mean weight loss with semaglutide at 16 weeks. Accordingly, tissue composition of the total weight loss shifted to greater loss of fat with enobosarm treatment as the median percentage of total body weight loss that is due to lean mass was 32% and estimated fat loss was 68% in the placebo + semaglutide group versus 9.4% lean vs 90.6% estimated fat loss in the all enobosarm + semaglutide group and 0.9% lean vs 99.1% estimated fat loss for enobosarm 3mg dose group. Therefore, enobosarm + semaglutide improved changes in body composition resulting in more selective and greater loss of adiposity than in subjects receiving placebo + semaglutide. Physical function was measured by the Stair Climb Test. Climbing stairs is an activity of daily living, and the Stair Climb Test measures functional muscle strength, balance and agility. Loss of lean mass mattered as 42.6% of patients on placebo + semaglutide had at least a 10% decline in stair climb power physical function. The all enobosarm + semaglutide group had a statistically significant and clinically meaningfully 54.4% mean relative reduction in the proportion of subjects that lost at least 10% stair climb power compared to placebo + semaglutide group (p=0.0049). Therefore, enobosarm treatment preserved lean mass (muscle) which translated to a reduction in the proportion of patients that had a clinically significant physical function decline versus subjects receiving semaglutide alone. SafetySafety data remains blinded as the extension clinical study is ongoing. The unblinded complete safety set will be available after the Phase 2b extension study is completed in April 2025. However, the aggregate, blinded safety data have not shown any significant differences compared to previous studies of enobosarm. The Independent Data Monitoring Committee met in October 2024 to evaluate the unblinded safety data, and they made the recommendation to continue the study as planned. With the positive topline results from the Phase 2b QUALITY study, the Company plans to move forward to request an end of Phase 2 meeting with FDA. About Sarcopenic ObesityThe clinical condition to improve body composition by preserving muscle and enhancing the loss of adiposity. We believe the market for this condition is quite large. Based on Medicare statistics, 22% of the US population is over 60 years of age, and according to the CDC, 42% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34 % of obese patients over the age of 60 have sarcopenic obesity, sarcopenia being age-related loss of muscle. This large subpopulation of sarcopenic obese patients is especially at risk when taking GLP-1 drugs for weight reduction as they may already have critically low amounts of muscle due to age-related muscle loss. Because of the magnitude and the speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty and muscle weakness in obese or overweight elderly patients. Muscle weakness may lead to poor balance, decreased gait speed, mobility disability, functional limitations, loss of independence, and higher risk for falls and fractures. In fact, the safety section of the package insert for Wegovy has been updated based on the recently reported SELECT cardiovascular outcomes clinical trial which now highlights a 400% increase in pelvic and hip fractures that was observed in patients greater than 75 years of age receiving Wegovy compared to placebo (2.4% versus 0.6%). Fractures of the hip and pelvis typically occur because of falls which increase with decreased muscle mass. 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 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 is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic 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. 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 full data set, including safety data, from the Phase 2b QUALITY study of enobosarm discussed above will be made available and whether that data will align with disclosed topline results or change any of the conclusions drawn from the topline data; whether and when the Company will present the full data from the Phase 2b QUALITY study and in what forum; whether and when patients will progress into the extension study; the planned design, number of sites, timing, endpoints, patient population and patient size of such extension study and whether such extension study will successfully meet any of its endpoints; whether and when the Company will have an end-of-Phase-2 meeting with FDA and the results of any such meeting; whether the results of the Phase 2b QUALITY study of enobosarm will be replicated to the same or any degree in any future Phase 3 studies; the expected costs, timing, patient population, design, endpoints and results of the planned Phase 3 studies of enobosarm as a body composition drug or any other Phase 3 studies; whether the Company and FDA will align on the Phase 3 program for enobosarm as a body composition drug and whether any such program will be able to be funded by the Company; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned Phase 3 study or other Phase 3 studies; whether FDA will require more than one Phase 3 study for enobosarm as a body composition drug; 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 in any planned or other Phase 3 studies or if approved, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will have a greater loss of adiposity or greater weight loss than with semaglutide alone; whether and when enobosarm will be approved by the FDA as a body composition drug; and whether sabizabulin will be developed for any ARDS indication. 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 Company's ability to reach agreement with FDA on study design requirements for the Company's planned clinical studies, including for the Phase 3 program for enobosarm as a body composition drug and the number of Phase 3 studies to be required and the cost thereof; 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; any products of the Company, 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; the Company's ability to protect and enforce its intellectual property; 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, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the 'SEC Filings' section of our website at Wegovy® is a registered trademark of Novo Nordisk A/S Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@ in to access your portfolio
