多尔生物宣布其DR10624用于治疗代谢功能障碍相关脂肪肝病和代谢功能障碍相关脂肪性肝炎的二期研究中，首例患者已给药-动脉网

Doer Biologics Announces First Patient Dosed in Phase 2 Study of DR10624 for Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis

CISION 等信源发布 2025-04-23 15:03

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HANGZHOU, China

中国杭州

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April 22, 2025

2025年4月22日

/PRNewswire/ -- Zhejiang Doer Biologics Co., Ltd. ('Doer Bio'), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers, today announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon receptor (GCGR), and Glucagon-like peptide-1 receptor (GLP-1R) has completed the dosing of the first patient in the Phase 2 study of DR10624 for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH)..

/PRNewswire/ -- 浙江道尔生物科技有限公司（“道尔生物”），一家专注于开发代谢疾病和癌症创新生物疗法的临床阶段生物医药公司，今日宣布其首创（FIC）三特异性激动剂DR10624，靶向成纤维细胞生长因子21受体（FGF21R）、胰高血糖素受体（GCGR）和胰高血糖素样肽-1受体（GLP-1R），已完成在治疗代谢功能障碍相关脂肪性肝病（MASLD）和代谢功能障碍相关脂肪性肝炎（MASH）的II期研究中首例患者的给药。

The Phase 2 study (DR10624-202) is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of three dose levels of DR10624 in adult subjects at high risk of liver fibrosis associated with MASLD. Key inclusion criteria include a liver fat content (LFC) ≥ 10%, as measured by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF), and liver stiffness (LSM) ≥ 8 Kpa, and < 15 Kpa, assessed via FibroScan®.

二期研究（DR10624-202）是一项随机、双盲、安慰剂对照的研究，旨在评估三种剂量的DR10624在高风险肝纤维化与MASLD相关的成年受试者中的疗效和安全性。主要纳入标准包括：通过磁共振成像衍生的质子密度脂肪分数（MRI-PDFF）测量的肝脏脂肪含量（LFC）≥ 10%，以及通过FibroScan®评估的肝硬度（LSM）≥ 8 Kpa且< 15 Kpa。

A total of 96 participants will be enrolled in the study. The primary endpoint of this study is relative percentage change from baseline in LFC, as measured by MRI-PDFF after 12 weeks of treatment..

共有 96 名参与者将被纳入研究。此项研究的主要终点是治疗 12 周后，通过 MRI-PDFF 测量的 LFC 较基线变化的相对百分比。

'DR10624 is a first-in-class long-acting tri-agonist targeting FGF21R, GLP-1R, and glucagon receptor (GCGR). Developed using Doer Bio's proprietary MultipleBody® platform technology, DR10624 was engineered to exhibit balanced activity for metabolic diseases. In non-clinical studies, DR10624 has shown remarkable, dose-dependent efficacy in liver protection and antihyperlipidemic activity, leading to reductions in steatosis, inflammation, and ballooning, as well as improved NAS scores in B6-Alms1-del mice—a spontaneous MASH model characterized by obesity, hyperglycemia, and dyslipidemia.' said .

“DR10624 是一种首创的长效三重激动剂，靶向FGF21R、GLP-1R和胰高血糖素受体（GCGR）。该药物利用Doer Bio公司专有的MultipleBody®平台技术研发而成，旨在展现针对代谢疾病的均衡活性。在非临床研究中，DR10624在肝保护和降血脂活性方面表现出显著的剂量依赖性疗效，减少了脂肪变性、炎症和气球样变，并改善了B6-Alms1-del小鼠（一种以肥胖、高血糖和血脂异常为特征的自发性MASH模型）的NAS评分。”

Yanshan Huang

黄岩山

, Ph.D., founder and Chief Executive Officer of Doer Bio.

博士，Doer Bio创始人兼首席执行官。

'We're pleased to announce the dosing of first patient in our Phase 2 study of DR10624 for the treatment of MASLD/MASH. Patients with MASLD face an increased risk of cardiovascular disease and type 2 diabetes, while MASH, a more severe form of MASLD, is a leading cause of liver failure globally. Without effective treatment, MASH can progress to cirrhosis, liver failure, and even hepatocellular carcinoma or death.

“我们很高兴地宣布，在我们针对MASLD/MASH治疗的DR10624二期研究中，已完成了首例患者的给药。MASLD患者面临更高的心血管疾病和2型糖尿病风险，而MASH作为MASLD的一种更严重形式，是全球肝衰竭的主要原因之一。如果没有有效治疗，MASH可能进展为肝硬化、肝衰竭，甚至肝细胞癌或死亡。

This DR10624-202 study is designed to determine the optimal dose of DR10624 for the treatment of MASLD/MASH. We are committed to advancing DR10624 as a potential treatment for patients affected by these serious liver diseases'. commented .

这项DR10624-202研究旨在确定DR10624治疗MASLD/MASH的最佳剂量。我们致力于推进DR10624作为这些严重肝病患者的潜在治疗方法。

Yongliang Fang

方永亮

, Ph.D., Chief Operating Officer of Doer Bio.

博士，Doer Bio首席运营官。

About Doer Bio

关于Doer Bio

Zhejiang Doer Biologics Co., Ltd. ('Doer Bio') is a clinical stage biopharmaceutical company that focuses on the discovery and development of multi-domain based multi-specific biotherapeutics to address unmet medical need in the field of metabolic diseases and cancers.

浙江道尔生物科技有限公司（“道尔生物”）是一家临床阶段的生物制药公司，专注于发现和开发基于多结构域的多特异性生物治疗药物，以满足代谢疾病和癌症领域未被满足的医疗需求。

Doer Bio has developed multiple proprietary platform technologies, including xLONGylation®, MultipleBody®, AccuBody®, and SMART-VHHBody.

多尔生物已经开发了多个专有平台技术，包括xLONGylation®、MultipleBody®、AccuBody®和SMART-VHHBody。

For more information about Doer Bio, please visit

有关Doer Bio的更多信息，请访问

www.doerbio.com

。

SOURCE Zhejiang Doer Biologics Co., Ltd.

来源：浙江多尔生物技术有限公司

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