Pemvidutide

Positive data from the IMPACT Phase 2b trial reinforces the potential for pemvidutide to be a highly differentiated MASH therapy Pemvidutide is the first product candidate to achieve statistically significant MASH resolution and weight loss at 24 weeks New data from the IMPACT trial demonstrates potentially class-leading improvements in corrected T1 (cT1), an important marker of liver inflammation and fibrosis End-of-Phase 2 Meeting with FDA expected in Q4 2025 Cash, cash equivalents and short-term investments of $183.1 million as of June 30, 2025 Webcast to be held today, August 12, 2025 , at 8:30 a.m. ET GAITHERSBURG, Md. , Aug. 12, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2025 and provided a business update. “Pemvidutide demonstrated rapid and robust MASH effects, meaningful weight loss and impressive safety and tolerability in the recently reported results from the IMPACT Phase 2b trial,” said Vipin K. Garg , Ph.D., President and Chief Executive Officer of Altimmune. “We are preparing for an End-of-Phase 2 Meeting with the FDA which will position us well for Phase 3 development. In addition, we look forward to reporting the full 48-week data in the fourth quarter and providing further updates as we continue to advance pemvidutide.” Dr. Scott Harris , Chief Medical Officer of Altimmune, commented, “The improvements in cT1 observed in the IMPACT trial were potentially class-leading among MASH clinical trials to-date. Reductions in cT1 are correlated with MASH resolution and fibrosis improvement. These new data along with the previously reported results from non-invasive tests of fibrosis, further strengthen the potential therapeutic value of pemvidutide.” Recent Highlights and Anticipated Milestones Metabolic Dysfunction-Associated Steatohepatitis (MASH) Reported positive 24-week top-line data from the IMPACT Phase 2b trial Statistically significant MASH resolution without worsening of fibrosis was observed in up to 59.1% of patients receiving pemvidutide Fibrosis improvement without worsening of MASH was observed in up to 34.5% of pemvidutide-treated patients Statistically significant improvements were observed across multiple objective measures of fibrosis, including supplemental AI-based analyses and non-invasive tests (NITs) of liver fibrosis, Enhanced Liver Fibrosis (ELF) score and Vibration-Controlled Transient Elastography (VCTE) Statistically significant weight loss of up to 6.2% at 24 weeks with a trajectory of continuing weight loss Potential for best-in-class tolerability without dose titration Fewer adverse event-related discontinuations with pemvidutide vs placebo Less than 1% treatment discontinuations due to adverse events in pemvidutide-treated patients New data on corrected T1 (cT1) imaging demonstrates potentially class-leading improvements in pemvidutide-treated patients cT1 is a highly reproducible MRI-based imaging method that measures the magnitude of liver inflammation and fibrosis. Decreases in cT1 relaxation time of 80 milliseconds (ms) or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies. In an analysis of imaging data from the IMPACT trial, mean decreases from baseline in cT1 relaxation time were 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared with a decrease of 27.5 ms in placebo (p < 0.001 for both) The IMPACT trial is ongoing with data on weight loss, NITs and safety at 48 weeks of treatment expected in the fourth quarter of 2025 End-of-Phase 2 Meeting with FDA targeted for fourth quarter of 2025 Statistically significant MASH resolution without worsening of fibrosis was observed in up to 59.1% of patients receiving pemvidutide Fibrosis improvement without worsening of MASH was observed in up to 34.5% of pemvidutide-treated patients Statistically significant improvements were observed across multiple objective measures of fibrosis, including supplemental AI-based analyses and non-invasive tests (NITs) of liver fibrosis, Enhanced Liver Fibrosis (ELF) score and Vibration-Controlled Transient Elastography (VCTE) Statistically significant weight loss of up to 6.2% at 24 weeks with a trajectory of continuing weight loss Potential for best-in-class tolerability without dose titration Fewer adverse event-related discontinuations with pemvidutide vs placebo Less than 1% treatment discontinuations due to adverse events in pemvidutide-treated patients Fewer adverse event-related discontinuations with pemvidutide vs placebo Less than 1% treatment discontinuations due to adverse events in pemvidutide-treated patients cT1 is a highly reproducible MRI-based imaging method that measures the magnitude of liver inflammation and fibrosis. Decreases in cT1 relaxation time of 80 milliseconds (ms) or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies. In an analysis of imaging data from the IMPACT trial, mean decreases from baseline in cT1 relaxation time were 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared with a decrease of 27.5 ms in placebo (p < 0.001 for both) Alcohol Use Disorder (AUD) Announced in May 2025 the initiation of RECLAIM, a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD RECLAIM is a randomized, placebo-controlled trial expected to enroll approximately 100 subjects, randomized 1:1, to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days per week at 24 weeks Key secondary endpoints include the proportion of subjects achieving a 2-level reduction in World Health Organization ( WHO ) risk drinking level and absolute change from baseline in average levels of phosphatidylethanol (PEth) a serum biomarker of alcohol intake RECLAIM is a randomized, placebo-controlled trial expected to enroll approximately 100 subjects, randomized 1:1, to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days per week at 24 weeks Key secondary endpoints include the proportion of subjects achieving a 2-level reduction in World Health Organization ( WHO ) risk drinking level and absolute change from baseline in average levels of phosphatidylethanol (PEth) a serum biomarker of alcohol intake Alcohol-Associated Liver Disease (ALD) Announced in July 2025 the initiation of RESTORE, a Phase 2 trial evaluating the safety and efficacy of pemvidutide in ALD RESTORE is a randomized, placebo-controlled trial expected to enroll approximately 100 subjects, randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 48 weeks The primary endpoint of the trial is the change from baseline in liver stiffness measurement (LSM), as measured by VCTE, at week 24 Key secondary endpoints include the change from baseline in LSM at week 48, changes in ELF score at weeks 24 and 48, and changes in alcohol consumption and body weight at both 24 and 48 weeks RESTORE is a randomized, placebo-controlled trial expected to enroll approximately 100 subjects, randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 48 weeks The primary endpoint of the trial is the change from baseline in liver stiffness measurement (LSM), as measured by VCTE, at week 24 Key secondary endpoints include the change from baseline in LSM at week 48, changes in ELF score at weeks 24 and 48, and changes in alcohol consumption and body weight at both 24 and 48 weeks Corporate Update Jerry Durso appointed by Altimmune Board of Directors to succeed Mitchel Sayare , Ph.D. as Chairman Appointment is part of the Board’s ongoing succession planning. It recognizes Mr. Durso’s extensive commercial and corporate development expertise and aligns with Altimmune’s planned advancement into Phase 3 development of pemvidutide in MASH. Dr. Sayare to continue to serve on the Board as an Independent Director Appointment is part of the Board’s ongoing succession planning. It recognizes Mr. Durso’s extensive commercial and corporate development expertise and aligns with Altimmune’s planned advancement into Phase 3 development of pemvidutide in MASH. Dr. Sayare to continue to serve on the Board as an Independent Director Financial Results for the Three Months Ended June 30, 2025 Altimmune reported cash, cash equivalents and short-term investments totaling $183.1 million as of June 30, 2025 , a 39% increase as compared to $131.9 million at December 31, 2024 Research and development expenses were $17.2 million for the three months ended June 30, 2025 , compared to $21.2 million in the same period in 2024, the decrease resulting from timing of clinical trial costs. The expenses for the quarter ended June 30, 2025 , included $11.2 million in direct costs related to pemvidutide development activities General and administrative expenses were consistent period-over-period at $5.7 million and $5.6 million for the three months ended June 30, 2025 and 2024, respectively Interest income was $1.1 million for the three months ended June 30, 2025 Net loss for the three months ended June 30, 2025 , was $22.1 million , or $0.27 net loss per share, compared to a net loss of $24.6 million , or $0.35 net loss per share, in the same period in 2024 Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. About PemvidutidePemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD) and obesity. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In the ongoing IMPACT Phase 2b trial, at Week 24, once-weekly pemvidutide demonstrated statistically significant MASH resolution without worsening of fibrosis, positive trends in liver fibrosis stage improvement without worsening of MASH, statistically significant reductions in non-invasive tests of fibrosis, weight loss, and liver fat content, and improvements in blood pressure. In a post-hoc AI-based analysis of the biopsies from the IMPACT trial, pemvidutide achieved a statistically significant reduction in liver fibrosis. In earlier trials, pemvidutide also demonstrated class-leading lean mass preservation and robust reductions in triglycerides and LDL cholesterol. Pemvidutide was well tolerated in the IMPACT trial, demonstrating potentially best-in-class tolerability among drugs in development for MASH with very low rates of discontinuation due to adverse events. The U.S. FDA granted Fast Track designation to pemvidutide for the treatment of MASH. The ongoing IMPACT Phase 2b MASH trial 48-week readout is expected in Q4 2025. In addition, RECLAIM, a Phase 2 trial in AUD and RESTORE, a Phase 2 trial in ALD, were initiated in May 2025 and July 2025 , respectively. About AltimmuneAltimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD) and obesity. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Forward-Looking StatementAny statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing RECLAIM, RESTORE and IMPACT Trials, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD, ALD and obesity, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission , including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC , which are available at www.sec.gov. Company Contact: Greg Weaver Chief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact: Lee Roth Burns McClellan Phone: 646-382-3403lroth@burnsmc.com Media Contact: Jake Robison Inizio Evoke CommsPhone: 619-849-5383jake.robison@inizioevoke.com This press release was published by a CLEAR® Verified individual. Source: Altimmune, Inc

摘要：罗氏近期宣布终止早期肥胖候选药物 RG7834 的开发，理由是 “缺乏市场竞争力”。这一决策虽未对其现有管线造成重大冲击，却折射出肥胖药领域的残酷竞争 —— 在 GLP-1 类药物主导市场的当下，新疗法需同时满足 “更高减重幅度、更优安全性、更便捷给药” 三大标准，任何短板都可能被淘汰。罗氏的退出为行业敲响警钟，也让中小药企的差异化突围之路更显艰难。一、决策背后：疗效与竞争力的双重短板RG7834 是罗氏针对肥胖开发的小分子 GLP-1 受体激动剂，处于 I 期临床阶段，原计划通过口服给药突破注射剂的依从性瓶颈。但在中期数据评估后，罗氏认为其 “减重效果与现有药物存在差距，且开发进度滞后”，最终选择放弃。从数据来看，RG7834 在健康受试者中的最大耐受剂量下，12 周体重降幅仅为 3.2%，远低于司美格鲁肽（10%+）和替尔泊肽（15%+）的临床数据。更关键的是，其口服生物利用度不足 8%，需每日高剂量给药才能起效，这可能增加胃肠道副作用风险。“在现有 GLP-1 药物已验证强大疗效的背景下，‘me-too’药物若无法实现突破，根本没有市场空间。” 伯恩斯坦分析师 Ronny Gal 评价道。开发进度的滞后加剧了困境。RG7834 进入 I 期时，诺和诺德的口服司美格鲁肽已完成 III 期试验，礼来的口服 GLP-1/GIP 双靶点药物也进入临床后期。罗氏内部评估显示，即使 RG7834 顺利推进，上市时间至少落后竞品 3-5 年，市场份额可能不足 2%。二、市场格局：GLP-1 类药物形成垄断壁垒罗氏的退出并非孤例，而是肥胖药市场 “马太效应” 的缩影。当前，GLP-1 受体激动剂已占据肥胖治疗市场的 85% 份额，其中诺和诺德的司美格鲁肽（Wegovy）和礼来的替尔泊肽（Mounjaro）形成双寡头格局，2024 年销售额分别达 180 亿美元和 150 亿美元。这类药物的优势不仅在于减重幅度，更在于代谢改善的 “附加价值”。司美格鲁肽在 SELECT 试验中证明可降低 39% 的主要心血管不良事件风险，替尔泊肽则能改善非酒精性脂肪肝（NAFLD），这些数据让其从 “减重药” 升级为 “代谢疾病修饰剂”，进一步巩固市场地位。相比之下，新进入者面临极高的门槛：单靶点 GLP-1 药物难以超越现有疗效，多靶点药物开发难度大（失败率超 60%），非 GLP-1 机制药物（如瘦素、胃饥饿素抑制剂）则尚未验证临床价值。“罗氏的决策是理性的 —— 与其在红海市场消耗资源，不如聚焦未被满足的领域。”Gal 分析道。三、突围路径：中小药企押注差异化技术在巨头聚焦 GLP-1 类药物的同时，中小 Biotech 正探索差异化路径：给药技术革新：Emisphere 的口服司美格鲁肽采用吸收增强剂，生物利用度提升至 15%，III 期试验显示 12 周减重 8.5%，已与默克达成合作；非 GLP-1 机制：Rhythm Pharma 的 setmelanotide（MC4R 激动剂）针对罕见肥胖综合征，虽适用人群窄，但减重幅度达 25%，年销售额突破 5 亿美元；联合疗法：Altimmune 的 pemvidutide（GLP-1/GCGR 双靶点）与每日一次的代谢调节剂联用，在 II 期试验中实现 19% 的体重降幅，计划 2026 年启动 III 期。这些尝试的共同特点是 “避开正面竞争”。例如，setmelanotide 专注单基因肥胖，与 GLP-1 药物形成互补而非对抗；口服制剂则瞄准对注射恐惧的患者，抢占细分市场。“巨头的垄断反而给了小企业生存空间，关键是找到‘巨头不愿做或做不好’的领域。” 一位 Biotech 创始人表示。四、行业启示：肥胖药研发的 “理性回归”罗氏的决策标志着行业从 “疯狂布局” 转向 “精准聚焦”。2021-2022 年肥胖药研发热潮中，超 50 家企业涌入 GLP-1 领域，如今已有 15 家终止相关项目，部分转向神经调控（如迷走神经刺激）、肠道菌群等更前沿的机制。对罗氏而言，此次调整是管线优化的一部分。该公司正将资源集中于阿尔茨海默病、多发性硬化等优势领域，同时通过合作（如与 EnteroBiotix 联合开发肠道菌群疗法）间接布局肥胖市场，降低自主研发风险。未来，肥胖药市场的竞争将更强调 “临床价值差异化”：不仅要减重，还要解决现有药物的痛点 —— 如停药反弹、胃肠道副作用、心血管保护等。“罗氏的退出不是结束，而是行业洗牌的开始。”Gal 预测，3-5 年内，真正能存活的新疗法将不超过 5 种，且均需具备 “不可替代性”。在这场关乎全球 20 亿肥胖人群的健康博弈中，药企的每一次决策都在重塑治疗格局。而对患者而言，竞争的终极意义在于：有朝一日，肥胖治疗能像糖尿病一样，拥有多样化、个体化的选择，而非被单一机制药物 “垄断”。参考来源：https://www.biospace.com/business/roche-drops-early-obesity-asset-citing-lack-of-competitiveness识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。