MetaVia在2025年欧洲肝病学会（EASL）大会上展示了关于DA-1241（一种GPR119激动剂）的数据，证明其在推测患有MASH的患者中具有肝脏保护和血糖调节的双重效果-动脉网

MetaVia Presents Data on DA-1241, a GPR119 Agonist, Demonstrating Both Hepatoprotective and Glucose-Regulating Effects in Patients with Presumed MASH, at the EASL Congress 2025

CISION 等信源发布 2025-05-07 14:00

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DA-1241 Significantly Decreased Plasma ALT levels, with a Mean Reduction of 22.8 U/L After 16 Week-Treatment

DA-1241 显著降低了血浆 ALT 水平，治疗 16 周后平均降低 22.8 U/L

Controlled Attenuation Parameter (CAP) Score Improved by 23.0 dB/m, Indicating Reduced Liver Fat Content

控制性衰减参数（CAP）评分改善了23.0 dB/m，表明肝脏脂肪含量减少。

Improvement in Systemic Inflammatory and Fibrosis Biomarkers Supports Beneficial Effects on Liver Health

全身炎症和纤维化生物标志物的改善支持对肝脏健康的有益作用

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

，

May 7, 2025

2025年5月7日

/PRNewswire/ --

MetaVia Inc.

元通公司

(Nasdaq:

（纳斯达克：

MTVA

), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH), demonstrates both hepatoprotective and glucose-regulating effects.

），一家专注于转化心代谢疾病的临床阶段生物技术公司，今天宣布了其针对推测为代谢功能障碍相关脂肪性肝炎 (MASH) 患者的新型 G 蛋白偶联受体 119 (GPR119) 激动剂 DA-1241 的 2a 期临床试验数据，结果显示该药物具有肝脏保护和血糖调节的双重作用。

The data will be presented in late-breaking poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place .

数据将在2025年欧洲肝病研究协会（EASL）大会上以最新突破性海报展示形式呈现。

May 7-10, 2025

2025年5月7日至10日

, in

，在

Amsterdam, the Netherlands

荷兰阿姆斯特丹

。

继续阅读

ALT & HbA1c

ALT 和 HbA1c

A total of 109 subjects with presumed MASH and qualifying baseline alanine transaminase (ALT) and imaging analysis were randomized to receive DA-1241 50 mg, DA-1241 100 mg alone, DA-1241 100 mg with a dipeptidyl peptidase 4 inhibitor (DPP4i), or placebo (PBO) in a 1:2:2:2 ratio, once daily for 16 weeks.

共有109名被认为患有MASH且基线丙氨酸转氨酶（ALT）和影像学分析符合要求的受试者，按照1:2:2:2的比例随机分配接受每日一次50毫克DA-1241、单独使用100毫克DA-1241、100毫克DA-1241联合二肽基肽酶4抑制剂（DPP4i），或安慰剂（PBO），持续16周。

The primary efficacy endpoint was the change from baseline in ALT after 16 weeks of treatment..

主要疗效终点是治疗 16 周后 ALT 从基线的变化。

'The full data from our Phase 2 clinical study, as presented at the prestigious EASL Congress, confirm that DA-1241 is the first oral GPR119 agonist to demonstrate both hepatoprotective and glucose-regulating effects in presumed MASH patients,' stated

“我们在第二阶段临床研究的全部数据，如在著名的EASL大会上所展示的，证实DA-1241是首个在推测的MASH患者中表现出肝脏保护和血糖调节作用的口服GPR119激动剂。”

Hyung Heon Kim

金亨宪

, President and Chief Executive Officer of MetaVia. 'Importantly, treatment with DA-1241 significantly reduced key markers of liver injury, inflammation, and fibrosis, while also improving non-invasive liver assessments such as CAP and FibroScan-AST (FAST) scores. In addition, DA-1241 efficiently improved glycemic control in patients with comorbid prediabetes and type 2 diabetes.

MetaVia公司总裁兼首席执行官表示：“重要的是，使用DA-1241治疗显著降低了肝损伤、炎症和纤维化的关键指标，同时改善了非侵入性肝脏评估指标，如CAP和FibroScan-AST（FAST）评分。此外，DA-1241还有效改善了患有前驱糖尿病和2型糖尿病患者的血糖控制。”

DA-1241 was well tolerated across patient groups, with a favorable safety profile. These results suggest that DA-1241's hepatoprotective effects are likely driven by its anti-inflammatory and anti-fibrotic actions rather than just glucose lowering, offering a promising multi-faceted therapeutic approach for patients at risk of progressive liver disease.

DA-1241在各患者群体中耐受性良好，安全性表现优异。这些结果表明，DA-1241的肝脏保护作用可能主要由其抗炎和抗纤维化作用驱动，而不仅仅是通过降低血糖，为面临进展性肝病风险的患者提供了一种前景广阔的多方面治疗策略。

Based on this data, we continue to believe that the novel mechanism of action of DA-1241 supports further development as either a monotherapy or combination therapy for MASH and metabolic diseases. We continue to conduct pre-clinical studies to explore other combination therapies for DA-1241, which may provide additional benefits to treat patients along the full spectrum on MASH.

基于该数据，我们继续认为 DA-1241 的新颖作用机制支持其作为单药疗法或联合疗法进一步开发，用于治疗 MASH 和代谢性疾病。我们正在进行临床前研究，探索 DA-1241 的其他联合疗法，这可能会为覆盖 MASH 全谱的患者提供额外的治疗益处。

We look forward reviewing these findings at an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025.'.

我们期待在2025年上半年与美国食品药品监督管理局（FDA）举行的第二阶段末会议上审查这些发现。

In subjects with baseline ALT levels between 40 and 200 U/L, DA-1241 treatment led to dose-dependent reductions in ALT, with the 100 mg dose producing a significant 22.8 U/L decrease after 16 weeks (p < 0.05 vs. placebo). These effects were observed regardless of diabetes status and were accompanied by improvements in non-invasive tests (NITs) used to monitor MASH progression such as FAST, CAP, MRI-PDFF and .

在基线ALT水平介于40至200 U/L的受试者中，DA-1241治疗导致了剂量依赖性的ALT降低，其中100 mg剂量在16周后使ALT显著降低了22.8 U/L（与安慰剂相比p < 0.05）。无论糖尿病状态如何，均观察到这些效果，并且伴随着用于监测MASH进展的非侵入性检测（NITs）的改善，例如FAST、CAP、MRI-PDFF等。

NIS-4

score. Specifically, the average FAST score declined from 0.559 to 0.371, indicating improvements in liver fibrosis and fat accumulation. Liver fat, measured by CAP, was reduced by 23.0 dB/m with DA-1241 100 mg compared to just 1.4 dB/m with placebo.

具体来说，平均FAST评分从0.559下降到0.371，表明肝纤维化和脂肪堆积有所改善。通过CAP测量的肝脂肪在使用DA-1241 100毫克后减少了23.0 dB/m，而安慰剂组仅减少1.4 dB/m。

Importantly, the 100 mg dose significantly lowered biomarkers of systemic inflammation (hs-CRP, CCL2) and fibrosis (TIMP1) (p < 0.05 vs. placebo), consistent with results from MASH mouse studies. Cytokeratin 18, a marker of liver cell death, also decreased significantly by 30.5% (p < 0.05 vs. placebo)..

重要的是，100毫克剂量显著降低了系统性炎症（hs-CRP、CCL2）和纤维化（TIMP1）的生物标志物（p < 0.05，与安慰剂相比），这与MASH小鼠研究的结果一致。肝细胞死亡标志物细胞角蛋白18也显著减少了30.5%（p < 0.05，与安慰剂相比）。

Beyond liver-related outcomes, DA-1241 100 mg produced rapid and significant reductions in hemoglobin A1c (HbA1c) of 0.37%p, 0.41%p, and 0.54%p at weeks 4, 8, and 16, respectively, from a baseline of 6.99%—despite nearly half of the participants being non-diabetic (p < 0.05 vs. placebo). In the subgroup of presumed MASH patients with type 2 diabetes, HbA1c decreased by 1.08%p.

除了与肝脏相关的结果外，DA-1241 100 mg 在第 4、8 和 16 周时，分别使糖化血红蛋白 (HbA1c) 快速显著降低了 0.37%、0.41% 和 0.54%，基线值为 6.99%，尽管近一半的参与者为非糖尿病患者（与安慰剂相比，p < 0.05）。在伴有 2 型糖尿病的疑似 MASH 患者亚组中，HbA1c 下降了 1.08%。

When 100 mg DA-1241 was co-administered with a DPP4 inhibitor pill preventing degradation of endogenous .

当100毫克DA-1241与一种防止内源性物质降解的DPP4抑制剂药片共同给药时。

GLP-1

, metabolic benefits were further enhanced without causing weight loss.

，代谢益处进一步增强，且不会导致体重减轻。

DA-1241 was well tolerated among presumed MASH patients, with no treatment-emergent adverse events (TEAEs) leading to discontinuation, except for one case in the placebo group.

DA-1241 在推测的 MASH 患者中耐受性良好，未出现导致治疗中断的治疗相关不良事件 (TEAE)，但安慰剂组有一例例外。

Presentation Details:

演示详情：

Title:

标题：

DA-1241, a GPR119 Agonist, Demonstrates Hepatoprotective and Glucose-Regulating Effects in a 16-week Randomized Placebo-Controlled Trial in Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients

DA-1241，一种GPR119激动剂，在一项为期16周的随机安慰剂对照试验中，显示出对推测患有代谢功能障碍相关脂肪性肝炎（MASH）患者的肝脏保护和血糖调节作用。

Presenting Author:

报告作者：

Rohit Loomba

罗希特·洛姆巴

, MD, MHSc, Professor of Medicine in the Division of Gastroenterology, and Adjunct Professor in the Division of Epidemiology at

医学博士，健康科学硕士，胃肠病学系医学教授，流行病学系兼职教授在

University of California, San Diego

加利福尼亚大学圣地亚哥分校

。

Final Abstract ID:

最终摘要ID：

LBP-005

Session:

会话：

Late Breaker Posters

最新突破海报

Presentation Start:

演示开始：

May 7, 2025

2025年5月7日

，

8:30 am CET

上午8点30分（欧洲中部时间）

A copy of the poster is available on the

海报的副本可以在

Posters

海报

section of the MetaVia website.

MetaVia网站的部分内容。

About DA-1241

关于DA-1241

DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides

DA-1241 是一种新型的 G 蛋白偶联受体 119 (GPR119) 激动剂，具有作为单一疗法和/或联合疗法治疗 MASH 和 2 型糖尿病 (T2D) 的开发选择性。GPR119 在肠道中的激动作用促进关键肠道肽的释放。

GLP-1

, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of DA-1241 has been demonstrated in multiple pre-clinical animal models of MASH and T2D where DA-1241 reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, .

，GIP 和 PYY。这些肽在葡萄糖代谢、脂质代谢和减肥方面发挥着进一步的作用。DA-1241 对葡萄糖、血脂谱和肝脏炎症具有有益效果，在临床前体内研究中已显示出潜在疗效。DA-1241 的治疗潜力已在多个 MASH 和 T2D 的临床前动物模型中得到证实，DA-1241 减少了肝脏脂肪变性、炎症、纤维化，并改善了葡萄糖控制。此外，在第一阶段1a期，。

and 2a trials, DA-1241 was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.

在2a期试验中，DA-1241在健康志愿者和2型糖尿病患者中均表现出良好的耐受性。在一项2a期临床研究中，DA-1241除了降低血糖的作用外，还展示了直接的肝脏作用。

About MetaVia

关于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.

MetaVia Inc. 是一家临床阶段的生物技术公司，专注于转化心血管代谢疾病。该公司目前正在开发用于治疗肥胖症的DA-1726，并正在开发用于治疗代谢功能障碍相关脂肪性肝炎 (MASH) 的DA-1241。DA-1726 是一种新型的氧抑胃泌素 (OXM) 类似物，可作为胰高血糖素样肽-1受体 (GLP1R) 和胰高血糖素受体 (GCGR) 的双重激动剂。

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.

OXM 是一种天然存在的肠道激素，可激活 GLP1R 和 GCGR，从而减少食物摄入同时增加能量消耗，因此与选择性 GLP1R 激动剂相比可能带来更显著的体重减轻效果。在一项针对肥胖症的 1 期多剂量递增（MAD）试验中，DA-1726 展现了同类最佳的减重、血糖控制和腰围减少潜力。

DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides .

DA-1241 是一种新型的 G 蛋白偶联受体 119 (GPR119) 激动剂，能够促进关键肠道肽的释放。

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..

，GIP 和 PYY。在临床前研究中，DA-1241 在肝脏炎症、脂质代谢、减重和葡萄糖代谢方面显示出积极效果，减少了肝脂肪变性、肝脏炎症和肝纤维化，同时改善了血糖控制。在一项 2a 期临床研究中，DA-1241 除了降低血糖的作用外，还表现出直接的肝脏作用。

For more information, please visit

欲了解更多信息，请访问

www.metaviatx.com

。

Forward Looking Statements

前瞻性声明

Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'believes', 'expects', 'anticipates', 'may', 'will', 'should', 'seeks', 'approximately', 'potential', 'intends', 'projects', 'plans', 'estimates' or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿中的某些陈述可能被视为1995年《私人证券诉讼改革法案》所指的前瞻性陈述。诸如“相信”、“预期”、“预计”、“可能”、“将”、“应该”、“寻求”、“大约”、“潜在”、“打算”、“项目”、“计划”、“估计”或这些词语的否定形式或其他类似表述（以及其他引用未来事件、条件或情况的词语或表达）旨在识别前瞻性陈述。

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co.

前瞻性声明是基于当前预期和假设的预测、推断及其他有关未来事件的陈述，因此受到风险和不确定性的制约。许多因素可能导致实际未来事件与此新闻稿中的前瞻性声明存在重大差异，包括但不限于：MetaVia执行其商业战略的能力相关的风险；我们对现有现金足以支持运营的预期；监管提交的时间表；通过MetaVia当前和未来产品候选物的开发步骤获得监管批准的能力；实现与东亚ST公司许可协议所带来的利益的能力。

Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's a.

有限公司，包括对MetaVia未来财务和经营结果的影响；MetaVia的合同制造商、临床研究合作伙伴及参与MetaVia当前和未来产品候选开发的其他各方的合作；MetaVia产品候选药物与它们所结合治疗的任何其他产品之间的潜在负面相互作用；MetaVia及时启动和完成临床试验的能力；MetaVia的a。

本新闻稿中的某些陈述可能被视为1995年《私人证券诉讼改革法》意义上的前瞻性陈述。诸如“相信”、“预期”、“预计”、“可能”、“将”、“应该”、“寻求”、“大约”、“潜在”、“打算”、“项目”、“计划”、“估计”或这些词语的否定形式或其他类似术语（以及其他引用未来事件、条件或情况的词语或表达）旨在识别前瞻性陈述。

前瞻性声明是基于当前预期和假设的关于未来事件的预测、展望及其他声明，因此受到风险和不确定性的制约。许多因素可能导致实际未来事件与本新闻稿中的前瞻性声明存在重大差异，包括但不限于：MetaVia执行其商业战略的能力相关的风险；我们对现有现金足以支持运营的预期；监管提交的时间表；通过MetaVia当前及未来产品候选物的开发步骤获得监管批准的能力；以及实现与Dong-A ST Co.许可协议带来的利益的能力。

有限公司，包括对MetaVia未来财务和经营结果的影响；MetaVia的合同制造商、临床研究合作伙伴及参与MetaVia当前和未来产品候选开发的其他各方的合作；MetaVia产品候选与其他治疗产品之间潜在的负面相互作用；MetaVia及时启动和完成临床试验的能力；MetaVia的a。

Contacts:

联系人：

MetaVia

元通

Marshall H. Woodworth

马歇尔·H·伍德沃斯

Chief Financial Officer

首席财务官

+1-857-299-1033

marshall.woodworth@metaviatx.com

马歇尔.伍德沃思@梅塔维亚tx.com