东曜药业完成DR10624治疗重度高甘油三酯血症的II期临床研究受试者入组-动脉网

Doer Biologics Completes Enrollment of the Phase 2 Clinical Study of DR10624 for Treatment of Severe Hypertriglyceridemia

CISION 等信源发布 2025-03-10 10:53

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HANGZHOU, China

中国杭州

，

March 9, 2025

2025年3月9日

/PRNewswire/ -- Zhejiang Doer Biologics Co., Ltd. ('Doer Bio'), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers,

/PRNewswire/ -- 浙江道尔生物科技有限公司（“道尔生物”），一家致力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，

today

今天

announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon receptor (GCGR), Glucagon-like peptide-1 receptor (GLP-1R) has completed the enrollment in the Phase 2 clinical study of DR10624 for the treatment of severe hypertriglyceridemia (SHTG) ('DR10624-201 study')..

宣布其首创的（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）、胰高血糖素样肽-1受体（GLP-1R），已完成用于治疗严重高甘油三酯血症（SHTG）的II期临床研究（“DR10624-201研究”）的受试者入组。

The DR10624-201 study is a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of three dose levels of DR10624 in adult SHTG patients, who have mean fasting triglycerides of greater than or equal to 5.65 mmol/L (500 mg/dL) at screening. A total of 79 SHTG patients have been enrolled in the 12 weeks study..

DR10624-201研究是一项随机、安慰剂对照、双盲研究，旨在评估三种剂量水平的DR10624在成人SHTG患者中的疗效和安全性，这些患者在筛选时平均空腹甘油三酯水平大于或等于5.65 mmol/L（500 mg/dL）。这项为期12周的研究共纳入了79名SHTG患者。

Yanshan Huang

黄岩山

, Ph.D., founder and Chief Executive Officer of Doer Bio, commented: 'DR10624 is a first-in-class long-acting tri-agonist targeting FGF21R, GCGR, and GLP-1R. Developed using Doer Bio's proprietary MultipleBody® platform technology, DR10624 was engineered to exhibit balanced activity for metabolic diseases.

博士，Doer Bio创始人兼首席执行官评论道：“DR10624 是一种首创的长效三重激动剂，靶向FGF21R、GCGR和GLP-1R。该药物利用Doer Bio专有的MultipleBody®平台技术研发，旨在展现针对代谢性疾病的平衡活性。”

In non-clinical and clinical studies, DR10624 has demonstrated extraordinary potency in reducing lowering triglycerides, normalizing blood lipids, and improving liver function.'.

在非临床和临床研究中，DR10624 已显示出非凡的降低甘油三酯、调节血脂和改善肝功能的效力。

Yongliang Fang

方永亮

, Ph.D., Chief Operating Officer of Doer Bio, added: 'We're excited to announce the successful completion of patient enrollment in the DR10624-201 study. There is growing awareness of the public health threat posed by SHTG. Patients with SHTG face an increased risk of developing acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD), conditions that elevate the risk of hospitalization and death.

博士，Doer Bio的首席运营官补充说：“我们很高兴地宣布DR10624-201研究的患者招募工作已顺利完成。公众对SHTG所带来的健康威胁的认识正在不断提高。SHTG患者面临更高的急性胰腺炎和动脉粥样硬化性心血管疾病（ASCVD）风险，这些病症增加了住院和死亡的风险。”

The DR10624-201 study aims to determine the optimal dose for advancing DR10624 as a novel biologic treatment for patients suffering from SHTG. The topline data is expected in the third quarter of 2025'..

DR10624-201研究旨在确定DR10624作为治疗SHTG患者的新型生物制剂的最佳剂量。预计将在2025年第三季度获得初步数据。

More information about the Phase 2 clinical trial is available at clinicaltrials.gov (NCT06555640)

有关第二阶段临床试验的更多信息，请访问 clinicaltrials.gov (NCT06555640)。

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®,

百欧生物已开发了多个专有平台技术，包括xLONGylation®，

MultipleBody®

多体®

, AccuBody®, and SMART-VHHBody.

，AccuBody®，以及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.