Enobosarm

MIAMI, FL, June 11, 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 the company will be participating in one-on-one meetings and a fire side chat presentation with investors at the virtual BTIG Obesity Health Forum on June 18, 2025. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. 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 as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.Obesity Program - Enobosarm is a next generation drug that makes weight reduction by GLP-1 RA more tissue selective for fat loss – Phase 2b QUALITY clinical studyThe Company has announced positive topline and safety 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 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management. After 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 in the second calendar quarter of 2025. As the Phase 2b QUALITY clinical trial is a positive study, we have requested an End of Phase 2 meeting with the FDA. Atherosclerosis Inflammation ProgramVeru has evolved its drug development strategy for sabizabulin and is exploring the possibility of the clinical development of sabizabulin, a novel oral broad anti-inflammatory agent, for the treatment of inflammation in atherosclerotic cardiovascular disease. The Company believes there are compelling scientific evidence and rationale to evaluate sabizabulin as a treatment for the inflammation associated with atherosclerotic cardiovascular disease. Atherosclerotic coronary artery disease (CAD) remains the leading cause of mortality worldwide. Inflammation and high cholesterol jointly contribute to atherosclerotic cardiovascular disease. It appears that the pathogenesis and progression of coronary artery disease, however, is largely driven by inflammation in response to atheromatous plaques containing cholesterol in the arterial wall. Even with maximum cholesterol reduction therapies, there remains a major and largely untreated residual inflammatory risk. The realization that the combined use of aggressive lipid-lowering and inflammation-inhibiting therapies might be needed to further reduce atherosclerotic risk has sparked the search for anti-inflammatory medications that could lower the risk of atherosclerotic events in patients with CAD. Sabizabulin has stable pharmacokinetics and low potential for drug-drug interactions; thus, sabizabulin may be administered potentially more safely as a secondary therapy in combination with statin therapy for the reduction of inflammation to slow the progression or promote regression of atherosclerotic cardiovascular disease. Overall preclinical data from in vitro and in vivo inflammation studies show that sabizabulin treatment suppressed all cytokines and chemokines tested. In Phase 2 and 3 pulmonary inflammation COVID-19 clinical studies, sabizabulin has demonstrated broad anti-inflammatory activity. The safety database consists of 266 dosed patients from the previous sabizabulin clinical development programs. The Company’s decision to explore this major cardiometabolic indication was based on the significant unmet medical need to treat inflammation in atherosclerotic cardiovascular disease, the large global market opportunity, current clinical and safety sabizabulin database of 266 patients, high probability of success given that sabizabulin drug’s mechanism of action is similar to colchicine, strong intellectual property position, and is consistent with Company’s focus on cardiometabolic diseases. Furthermore, the Company believes sabizabulin may be evaluated in a small Phase 2 dose finding proof of concept study to assess high sensitivity CRP and the progression of coronary atherosclerosis in patients using as the primary endpoint coronary plaque volume and composition measured by coronary CT angiography imaging. The chronic nonclinical toxicology studies are expected to be completed and a new IND for the proposed indication is planned to be submitted by the first half calendar 2026. Veru currently has sufficient drug substance to supply the proposed Phase 2 clinical study. 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 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

▲8月1-2日 2025生物医药创新博览会 扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。Veru公布2b期QUALITY研究积极安全性结果：与单用司美格鲁肽相比，enobosarm联合司美格鲁肽可实现更多脂肪减少、肌肉保留及更低胃肠道副作用—2b期QUALITY临床研究顶线安全性数据显示，enobosarm+司美格鲁肽组合相较单用司美格鲁肽具有更优安全性———基于2b期QUALITY试验疗效与安全性数据，3mg enobosarm将作为拟定口服剂量进入3期临床项目———与单用司美格鲁肽相比，3mg enobosarm联合治疗额外降低胃肠道副作用（腹泻、恶心和胃食管反流病）发生率———enobosarm 3mg联合司美格鲁肽可实现高度选择性减脂（占总减重量的99%），同时维持瘦体重———凭借2b期QUALITY研究的积极结果，Veru已申请与FDA召开2期结束会议，以明确3期临床项目的监管路径———评估enobosarm单药治疗能否防止停用司美格鲁肽后脂肪与体重反弹的2b期扩展维持研究顶线数据预计于第二季度公布—— 佛罗里达州迈阿密，2025年5月28日——专注于开发治疗心脏代谢和炎症性疾病创新药物的晚期临床阶段生物制药公司Veru Inc.（纳斯达克股票代码：VERU）今日宣布，其2b期QUALITY临床研究获得积极顶线安全性结果。这项多中心、双盲、安慰剂对照、随机剂量探索试验旨在评估3mg/6mg enobosarm或安慰剂在老年（≥60岁）慢性体重管理患者接受司美格鲁肽（Wegovy®）治疗时，对增强减脂和预防肌肉流失的安全性与疗效。2b期QUALITY临床试验积极顶线安全性结果不良事件（AEs）及特别关注不良事件（见下表）：在2b期QUALITY临床试验中，enobosarm与司美格鲁肽GLP-1受体激动剂组合展现出良好安全性。与安慰剂组（单用司美格鲁肽）相比，任何剂量enobosarm均未导致胃肠道副作用增加、未出现符合Hy定律的药物性肝损伤证据、也未加重阻塞性睡眠呼吸暂停。男性患者未出现前列腺特异性抗原升高的AE，女性患者未出现男性化相关AE。哥伦比亚自杀严重程度评定量表未报告自杀意念案例。QUALITY研究中未观察到治疗相关严重不良事件（SAEs），4例非治疗相关SAEs均匀分布于各治疗组。在拟定3mg enobosarm的3期临床项目剂量下，1名受试者出现短暂性丙氨酸氨基转移酶（ALT）轻度升高AE，持续用药后自行恢复至基线水平，且未伴随天冬氨酸氨基转移酶（AST）、碱性磷酸酶或总胆红素升高。与安慰剂+司美格鲁肽组相比，3mg enobosarm联合治疗组在特定胃肠道副作用（腹泻、恶心和胃食管反流病）的报告率更低。"这项2b期研究的安全性结果令人鼓舞，表明在司美格鲁肽治疗基础上加用enobosarm不会加重胃肠道副作用，某些情况下甚至可能有所改善，"肥胖症专家、美国肥胖协会前主席、Veru科学顾问Louis J. Aronne医学博士表示。2b期QUALITY临床试验安全性概要Veru公司董事长、总裁兼首席执行官Mitchell Steiner医学博士表示："我们此前公布的2b期QUALITY研究积极结果表明，在使用司美格鲁肽减重的老年患者中，enobosarm能选择性增强减脂效果，同时保持瘦体重和身体功能。今日公布的安全性数据进一步证实，enobosarm不仅具有良好安全性，还能减轻患者使用司美格鲁肽等GLP-1受体激动剂时常见的胃肠道副作用。基于这些疗效与安全性数据，我们已选定3mgenobosarm剂量推进至拟开展的3期研究。我们已向FDA提交2期结束会议申请，预计将于2025年第三季度召开。该会议将为我们规划中的3期临床项目设计方案提供监管指导。此外，本季度我们还将获得2b期扩展维持研究的顶线结果，这将揭示enobosarm单药治疗能否阻止患者停用GLP-1受体激动剂后常见的脂肪与体重反弹。我们期待未来在权威科学会议和顶级期刊上公布完整的2b期QUALITY研究及扩展临床试验数据。"2b期QUALITY临床研究积极顶线疗效结果：enobosarm联合GLP-1受体激动剂实现脂肪选择性减少，同时维持瘦体重与身体功能2025年1月，公司公布了2b期QUALITY研究的积极顶线结果。这项多中心、双盲、安慰剂对照、随机剂量探索试验旨在评估3mg/6mgenobosarm或安慰剂在老年（≥60岁）慢性体重管理患者接受司美格鲁肽（Wegovy®）治疗时，对增强减脂和预防肌肉流失的疗效。顶线疗效结果主要终点——瘦体重变化百分比疗效分析显示，治疗16周时，所有enobosarm+司美格鲁肽组患者相较安慰剂+司美格鲁肽组在总瘦体重指标上均达到预设主要终点，具有统计学显著性和临床意义（瘦体重流失相对减少71%，p=0.002）。其中3mg剂量组表现最优，瘦体重流失平均相对减少99.1%（p<0.001），6mg剂量组未显示出额外优势。关键次要终点：脂肪总量enobosarm联合治疗呈现剂量依赖性减脂效果，6mg组16周时相较安慰剂组脂肪流失相对增加46%（p=0.014）减重成分构成虽然DEXA检测显示联合治疗组与单用司美格鲁肽组16周时平均减重相似，但enobosarm治疗使减重成分更倾向于脂肪选择性减少：安慰剂组：瘦体重减少占总体重减轻的32%，脂肪减少占68%3mg enobosarm组：瘦体重减少仅占0.9%，脂肪减少高达99.1%爬楼梯测试评估身体功能该测试通过测量功能性肌肉力量、平衡与敏捷度反映日常生活能力。老年人爬楼梯能力下降预示行动障碍、步态异常、跌倒、骨折、住院及死亡风险增加。参考Van Roie E等学者研究（《PLOS ONE》2019），自然衰老每年导致爬楼梯功率下降1.38%。测试结果：以16周时爬楼梯功率下降＞10%（相当于自然衰老约7.5年的功能衰退）为界值进行分析：安慰剂组42.6%患者出现≥10%功能下降3mg enobosarm组仅16%患者出现下降，相对减少62.4%（p=0.0066）6mg组下降率为22.5%，相对减少46.2%（p=0.0505）疗效结论这项开创性研究首次证实：接受司美格鲁肽治疗的肥胖/超重老年患者面临瘦体重加速流失及身体功能衰退风险。enobosarm联合治疗使减重成分99%来自脂肪，同时保留肌肉质量并改善身体功能。该药物通过驱动脂肪选择性减少、维持瘦体重与身体功能，为接受GLP-1受体激动剂治疗的患者提供了改善体成分的新选择。2b期扩展维持研究完成剂量探索阶段后，所有受试者停用司美格鲁肽，继续接受盲法安慰剂、3mg或6mg enobosarm单药治疗12周。该扩展研究将验证enobosarm能否通过维持肌肉量防止停用GLP-1受体激动剂后的脂肪反弹，顶线结果预计本季度公布。后续监管计划基于2b期积极结果，我们计划向FDA提交与2期QUALITY研究设计相似的3期临床试验方案：在符合GLP-1受体激动剂治疗条件的肥胖/超重老年患者（≥60岁）中，开展enobosarm口服制剂与Wegovy®（司美格鲁肽）和/或Zepbound®（替尔泽肽）联用的双盲安慰剂对照研究。主要终点为24周时爬楼梯测试评估的身体功能改善，次要终点包括瘦体重、脂肪量、胰岛素抵抗和糖化血红蛋白变化。治疗24周后将继续随访至68周，评估体成分、骨密度等指标的长期获益。新型缓释口服制剂研发进展Veru正在开发具有专利潜力的enobosarm改良缓释口服制剂，相关配方、药代动力学特征及制备工艺将申请专利保护（预计专利有效期至2045年）。该制剂已完成动物试验，预计2025年上半年进入1期生物利用度临床试验，将为3期研究及商业化提供支持。 版权声明：本文转自华创新药，如不希望被转载的媒体或个人可与我们联系，我们将立即删除植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐