--During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo-- --The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the placebo group at the end of the study-- --Enobosarm monotherapy had ...

文章核心观点 公司是临床后期生物制药公司 专注开发治疗心脏代谢和炎症性疾病创新药物 宣布将参加虚拟BTIG肥胖健康论坛 并介绍了两款药物的研发进展和策略 [1][2] 公司概况 - 公司是临床后期生物制药公司 专注开发治疗心脏代谢和炎症性疾病创新药物 [2] - 公司药物开发项目包括两款后期新型小分子药物 enobosarm和sabizabulin [2] 肥胖项目 - enobosarm - enobosarm是下一代药物 可使GLP - 1 RA减重更具组织选择性 减少脂肪并保留瘦肌肉质量 [2][3] - 公司公布了2b期QUALITY临床研究的积极 topline和安全结果 该研究评估enobosarm 3mg、6mg或安慰剂辅助脂肪减少和预防肌肉损失的安全性和有效性 [3] - 参与者进入2b期扩展研究 停用semaglutide 继续接受安慰剂、enobosarm 3mg或6mg单药治疗12周 评估enobosarm是否能防止停用GLP - 1 RA后脂肪反弹 扩展研究的 topline疗效和安全结果预计在2025年第二季度公布 [3] - 因2b期QUALITY临床试验结果积极 公司已请求与FDA进行2期结束会议 [3] 动脉粥样硬化炎症项目 - sabizabulin - 公司探索sabizabulin用于治疗动脉粥样硬化性心血管疾病炎症的临床开发可能性 [4] - 动脉粥样硬化性冠状动脉疾病是全球主要死因 炎症和高胆固醇共同导致该疾病 即使采用最大程度降低胆固醇的疗法 仍存在大量未治疗的残余炎症风险 [4] - sabizabulin药代动力学稳定 药物相互作用可能性低 可与他汀类药物联合作为二级疗法 减少炎症 延缓或促进动脉粥样硬化性心血管疾病的消退 [4] - 临床前数据显示sabizabulin可抑制所有测试的细胞因子和趋化因子 在2期和3期肺部炎症COVID - 19临床研究中 显示出广泛的抗炎活性 [4] - 公司基于未满足的医疗需求、全球市场机会、现有临床和安全数据库、高成功概率、强大的知识产权地位等因素 决定探索该适应症 [5] - 公司计划进行小型2期剂量探索概念验证研究 以冠状动脉斑块体积和组成作为主要终点 慢性非临床毒理学研究预计在2026年上半年完成 并提交新的IND申请 公司目前有足够的药物物质供应拟议的2期临床研究 [5][6]

整理 | GLP1减重宝典内容团队 Veru公司（纳斯达克代码：VERU）是一家处于后期临床阶段的生物制药公司，致力于开发治疗心代谢及炎症性疾病的创新药物。公司近日公布 了其2b期QUALITY临床试验的积极初步安全性数据。该研究是一项多中心、随机、双盲、安慰剂对照、剂量探索性试验，旨在评估enobosarm （3mg或6mg）在接受司美格鲁肽进行长期体重管理的老年患者（≥60岁）中的安全性和有效性。 Enobosarm联合司美格鲁肽的安全性表现 ** 全部为轻度，恢复或接近正常，无其他肝功能指标升高 疗效结果：enobosarm提高脂肪选择性减少，保护瘦体重和身体功能 2025年1月，Veru曾公布QUALITY试验的积极疗效数据。该研究评估enobosarm在接受司美格鲁肽治疗的老年人中，是否能防止肌肉流失并增强 脂肪减少。 主要终点：总瘦体重变化百分比 研究显示， enobosarm与司美格鲁肽联用具有良好的安全性。联合治疗未引发胃肠道不良反应的增加 ，亦无任何药物性肝损伤（根据Hy's法 则）的迹象，也未见阻塞性睡眠呼吸暂停的发生率上升。男性未观察到前列腺特异性抗原（PSA）升高，女性未出现男性化现象 ...

--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 semaglut ...

Veru ( NASDAQ: VERU ) is a late-clinical-stage biopharma company emerging from a comprehensive restructuring effort in 2024. After divesting its commercial sexual health business for $18 million in 2024, Veru has pivoted toward an entirely new Analyst's Disclosure: I/we have a beneficial long position in the shares of VERU either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeki ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 (State of Incorporation ...

-- Moderated discussion with preeminent obesity expert, Louis J. Aronne, MD, FACP and Mitchell Steiner, M.D., F.A.C.S, President, CEO, and Founder, of Veru -- MIAMI, FL, May 08, 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 release of a Virtual Investor KOL segment featuring Louis J. Aronne, MD, FACP. As part of the segment, Mitch ...

Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Samuel Fisch - Executive Director of Investor Relations & Corporate CommunicationsMitchell Steiner - Chairman, President & CEOMichele Greco - CFO & Chief Administrative OfficerAnthea Li - Equity Research AssociateGary Nachman - Managing Director - Equity ResearchGary Barnette - Chief Scientific OfficerEduardo Martinez-Montes - Biotechnology Equity Research Associate Conference Call Participants William Wood - Equity Research Ana ...

Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fish, Veru Inc. Executive Director, Investor Relations and Corporate Communications. Please go ahead, sir. Speaker1 Statements made on this conference call may be forward looking statements. Forward looking statements may include, but are not necessarily l ...

Exhibit 99.1 Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Veru Reports Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress —Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 — —Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 — —With positive Phase 2b QUALITY study, Ve ...