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).

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®. 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.

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

"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. 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 Yongliang Fang, Ph.D., Chief Operating Officer of Doer Bio.