Survodutide

Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability with Longer-Term Exposure to DA-1726 and Further Explore Non-Titrated Maximum Tolerated Dose Top-Line Data Expected in the Fourth Quarter of 2025 CAMBRIDGE, Mass., Aug. 6, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has extended to 8 weeks from 4 weeks, the 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, and has administered a fifth weekly dose to the first patient. DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The extension is designed to further explore the non-titrated maximum tolerated dose, explore safety and other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy. Top-line data is expected in the fourth quarter of 2025. "Extending DA-1726 administration by an additional 4 weeks—for a total of 8 weeks—in the 48 mg cohort represents a meaningful step forward as we seek to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "After reviewing the original trial design and previous results, we feel confident that the 4-week extension can potentially provide more robust data, which we believe may position DA-1726 more strongly against current treatments and those in late-stage clinical trials. By extending exposure to the drug, we aim to more fully evaluate DA-1726's therapeutic profile across primary, secondary and exploratory endpoints—including safety, tolerability, body weight, waist circumference, and body mass index (BMI), among others—and to further unlock its full therapeutic potential. Previously reported data from the 32 mg dose demonstrated strong weight loss effects (mean: 4.3%, max: 6.3% by Day 26), early satiety in 83% of patients, and waist reductions of up to 3.9 inches by Day 33. These findings, along with favorable glycemic and cardiovascular safety and a mild, transient GI profile, suggest that DA-1726-may offer a superior tolerability profile compared to existing GLP-1 therapies." Mr. Kim added, "We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors may offer a differentiated safety profile that addresses the well-documented tolerability issues seen with current GLP-1 agonists, where discontinuation rates reach 20–30% within the first month and up to 70% within a year. We look forward to reporting top-line data from the extended 48 mg cohort later this year, which may further validate DA-1726's longer-term safety, early efficacy and differentiated tolerability profile compared to current GLP-1 therapies." The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The study enrolled healthy adults with a minimum body mass index (BMI) between 30 – 45 kg/m2. Nine subjects in each cohort are randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort will add 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE MetaVia Inc. 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超140年历史全球大药厂勃林格殷格翰持续基业长青的密码，内化于“创新”二字之中。上海静安寺越洋国际广场办公室里，一场热情洋溢的员工见面会如期举行。于2025年7月1日接任勃林格殷格翰（以下简称“勃林格”）全球执行董事会主席并继续兼任人用药品业务负责人的Shashank Deshpande，将上任后全球业务巡访的第一站落脚在中国。被员工围聚在中间的Shashank，逐一回应了中国区员工对公司未来发展及中国区战略的各类问题。事实上，这也是外界对这家拥有超140年历史、全球最大家族药企的核心关注点。2023年，勃林格殷格翰以稳健的业绩增速成为德国最大制药企业，并在近两年稳居全球制药企业前20强。与所有跨国药企一样，这家去年全球营收达268亿欧元的制药巨擘，需在地缘因素频现的当下锚定技术赛道与疾病领域，进一步探索多元化商业经营模式，确保后续稳健可持续发展。这也恰是包括Shashank在内、所有跨国药企掌舵人必须在实践中回答的问题。在勃林格中国区员工见面会当天的专访中，Shashank告诉E药经理人，勃林格正通过提升组织能力、拓展疾病领域版图、深耕创新生态、激活全球人才等关键举措，开启“迈向2035”战略。其中，中国市场扮演重要角色——在勃林格全球规划中，中国有望打造成为其全球第二大市场。勃林格殷格翰全球执行董事会主席兼人用药品业务负责人Shashank Deshpande01新产品组合格局已现评估一家跨国药企竞争力的核心指标，是现有产品组合的持续性、未来产品组合的潜力，以及两者能否实现无缝衔接，以规避“专利悬崖”带来的业绩下滑风险。Shashank用“激动人心”描述现阶段勃林格的创新布局：“我们正处在新增长阶段的起点，预计将在多个治疗领域推出新产品。”众所周知，勃林格同时拥有人用药品和动物保健两大业务板块，前者营收占比超80%。在人用药品领域，勃林格在呼吸系统疾病领域有百年积淀，是其传统优势领域；本世纪初，随着欧唐宁®（利格列汀）、欧唐静®（恩格列净）获批上市，其优势领域进一步拓展至心血管、肾脏和代谢领域。截至2025年上半年，勃林格已上市产品组合中，代谢领域的恩格列净系列与呼吸领域的维加特®（尼达尼布）分别位列全球年营收第一和第二，占人用药品板块总营收的55%，与2024年持平。如今，在深耕原有两大疾病领域的基础上，勃林格将关注点拓展至肿瘤和免疫领域，同时推进精神健康和视网膜疾病疗法开发。2025年半年报显示，勃林格未来12至18个月内，将启动超过10项新的II期和III期临床试验，覆盖多个治疗领域，有望在未来五年内将一系列重要产品推向市场。“从全球范围看，恩格列净系列的生命周期还将延续，但产品组合更新确实是我们的首要任务。”Shashank在专访中着重提及3个新产品，分别来自肿瘤、代谢和呼吸领域——与勃林格一贯秉持的“解决临床痛点”研发理念一致，这些产品均具备“同类最佳（BIC）”或“同类首创（FIC）”特质。严格来说，勃林格殷格翰是“重回”肿瘤领域。其肿瘤布局始于本世纪初，2013年上市首款肿瘤药阿法替尼（Giotrif）——这是全球首个不可逆ErbB家族抑制剂，属于第二代口服小分子EGFR TKI。此次回归，Shashank寄予厚望的产品是zongertinib。Zongertinib是一款用于治疗人表皮生长因子受体2（HER2）突变阳性晚期非小细胞肺癌（NSCLC）的靶向疗法，在经治患者中展现出持久且具有临床意义的疗效，超过70%的患者实现肿瘤缓解。据悉，该药目前正在美国、日本和中国药监机构的注册审批中，其作为一线疗法的全球III期临床试验正在进行中，预计2025年下半年将在美国获批上市。Shashank特别强调其剂型优势：“Zongertinib为口服剂型，这种创新将极大便利患者使用。”另一款勃林格殷格翰寄予厚望，且有望在2025年下半年获批上市的新产品是nerandomilast，来自其有着长期积淀的呼吸系统疾病领域。作为特发性肺纤维化（IPF）和进展性肺纤维化（PPF）领域首个PDE4B抑制剂类分子，它是近10年来首个在IPF和PPF领域III期临床达到主要终点的新药。目前，该药已向美国、欧盟、中国及日本的药监机构递交上市申请，并获得FDA和CDE的优先审评资格。此外，备受产业界关注、也是Shashank常被问及的在研新药是survodutide。作为新型胰高血糖素受体/胰高血糖素样肽-1受体（GCGR/GLP-1R）双重激动剂，由勃林格殷格翰与丹麦创新药企Zealand Pharma联合研发，其II期临床试验数据显示，有望成为治疗代谢功能障碍相关脂肪性肝炎（MASH）的最佳疗法。作为当前爆火的GLP-1技术赛道中的差异化选手，产业界聚焦其III期临床试验结果能否延续II期的惊艳表现。Shashank表示：“Survodutide的III期临床正在进行中，我们同样期待看到结果。”据悉，该药已获美国和中国的突破性疗法认定。新产品组合的逐步清晰为Shashank推动勃林格进入新增长阶段带来底气，但他也坦言，这对“此前专注于一两个疾病领域的勃林格殷格翰”而言，是种挑战。他列举了很多正在思考的问题，比如：“如何为增长提供资源？如何保持速度？如何在3-4个治疗领域同时保持竞争力？如何从战略和执行层面获取人才？”医药行业的通识认知是：新药是基础，而借新药实现增长的路径是市场塑造——尤其对FIC和勃林格殷格翰C而言，本质上是对医生、患者、医疗标准与规范固有理念的挑战。于是，Shashank将中国市场视为验证未来10年战略可行性的“灵感之地”。采访中，他多次提及中国药审改革10年来在医药创新生态构建上的巨大成就，以及伴随生态完善积淀的人才与创新技术优势。02中国力量融入全球创新“想想未来十年将会发生什么，以及中国将在创新领域做出多大贡献，是一件令人欣喜的事。”这或许是Shashank仅仅时隔3个月，便以全球执行董事会主席新身份再次到访中国的原因。若为Shashank此次中国行制定“任务清单”，核心包括以下4项：如何更快地将全球创新惠及中国患者；如何让中国创新更好地融入勃林格全球创新体系；如何激发中国人才潜能服务全球战略目标；如何将中国市场打造为勃林格全球第二大医药市场。Shashank表示，这些是他履新以来时刻思考的问题。事实上，第一项任务已阶段性完成。受益于中国药审改革的有力推进，2018年勃林格殷格翰启动“中国纳入”计划，默认中国加入所有全球注册临床试验，实现中美欧同步申报；一年后，该计划升级为“中国关键”，将中国全面纳入全球早期临床开发（Ⅰ/Ⅱ期），打破“欧美为先”模式。此后，勃林格持续深化本土创新生态建设，与32家医疗机构签署临床研究框架协议，加速临床试验启动。2024年，勃林格殷格翰旗下一款用于罕见皮肤病治疗药物的新适应症在中国首发，早于欧美市场；未来，其在肿瘤、代谢、呼吸领域的新产品组合也将基本实现中国与全球同步。“未来五年，我们计划在中国投入50亿元用于研发，其中人用药品领域的研发投入占到35亿元，目标是在人用药品领域获得25项以上新的注册获批成果。”Shashank说。“让中国创新嵌入勃林格全球创新体系”也有了实质性动作。勃林格殷格翰正与苏州瑞博生物合作开发基于小核酸的非酒精性脂肪性肝炎（NASH）/代谢相关脂肪性肝炎（MASH）疗法；此外，已在上海、北京、深圳设立联合外部创新孵化器，并与北京大学等学术机构建立合作。“激发中国人才潜能服务全球战略目标”也已启动。Shashank认为，一切业务的基础是人才，而让勃林格全球员工的经验流动，是激活人才、更有力推进战略目标的有效工具。2024年，勃林格中国启动“Think China”计划，目标是将中国打造成为全球人才枢纽，推动人才培养与交流。“我们希望将全球化融入中国市场，赋能本土人才不仅在中国，更在全球舞台发挥领导作用。”以“迈向2035”战略为引导，勃林格殷格翰全球开启新增长阶段，这也将带动中国市场增长。“勃林格中国区战略既在演进又保持一致性”，战略重点始终聚焦于“能产生重大影响、为患者创造最大价值的领域”。在此理念支撑下，勃林格殷格翰资源配置的底层逻辑是“集中资源于核心专长与创新领域”。过去一两年，其在华的战略调整（包括肿瘤管线及部分成熟产品的外部合作）均基于此。“我们持续适应动态变化的中国市场，寻求新合作，探索创新解决方案以应对未被满足的医疗需求。”Shashank表示。创新成果持续涌现，人才潜能不断激发，叠加勃林格过去30年在华构建的从研发到生产、从动物保健全球创新到数字创新的独特全价值链，让Shashank“将中国打造为勃林格殷格翰全球第二大医药市场”的目标，不仅是战略蓝图上的规划，更成为看得见、可触及的未来。一审| 黄佳二审| 李芳晨三审| 李静芝