道尔生物完成DR10624治疗重度高甘油三酯血症的2期临床研究的全部患者入组

2025/03/10

查看原文

384

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

Hangzhou, Zhejiang, China, March 10, 2025, 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), 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”).

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.

Dr.Yanshan Huang

Founder ＆ CEO of Doer Bio

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

Dr.Yongliang Fang

COO of Doer Bio

Yongliang Fang, 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. 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”.

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

About 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.

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

For more information about Doer Bio, please visit www.doerbio.com.

GCGR相关推荐