Doer Biologics Doses First Patient in Phase 2 Trial of DR10624 for MASLD/MASH
Doer Biologics
Biological Drug Developer
Hangzhou, Zhejiang, China, April 22, 2025 – Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics"), a clinical-stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancer, today announced that the first patient has been dosed in the Phase II clinical trial of DR10624, its self-developed first-in-class (FIC) long-acting trispecific agonist targeting Fibroblast Growth Factor 21 Receptor (FGF21R), Glucagon Receptor (GCGR), and Glucagon-like Peptide-1 Receptor (GLP-1R), for the treatment of Metabolic Associated Steatotic Liver Disease (MASLD)/Metabolic Associated Steatohepatitis (MASH).
DR10624-202 is a randomized, double-blind, placebo-controlled Phase II clinical study aimed at evaluating the efficacy and safety of three different dose levels of DR10624 injection in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk of liver fibrosis. The main inclusion criteria for this study include: liver fat content (LFC) ≥10% (measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)); liver stiffness measurement (LSM) ≥8 Kpa and <15 Kpa (assessed by FibroScan®). The DR10624-202 study will recruit 96 subjects. The primary endpoint of the study is the relative percentage change in liver fat content (LFC), as measured by MRI-PDFF, from baseline after 12 weeks of treatment.
Dr. Huang Yanshan
Founder & CEO of Doer Biologics
Dr. Huang Yanshan, founder and CEO of Doer Biologics, stated: "DR10624 is a first-in-class long-acting triple agonist targeting FGF21R, GCGR, and GLP-1R. DR10624 was developed using Doer Biologics' proprietary MultipleBody® platform technology, designed to demonstrate balanced activity in metabolic diseases. In non-clinical studies, DR10624 showed significant dose-dependent efficacy in liver protection and anti-hyperlipidemia activity in B6-Alms1-del mice (a spontaneous MASH model characterized by obesity, hyperglycemia, and dyslipidemia), reducing steatosis, inflammation, and ballooning, while improving NAS scores."
Dr. Yongliang Fang
Chief Operating Officer of Doer Biologics
Dr. Yongliang Fang, Chief Operating Officer of Doer Biologics, commented: "We are pleased to announce that the first patient has been dosed in the Phase 2 study of DR10624 for the treatment of MASLD/MASH. Patients with MASLD have a higher risk of cardiovascular disease and type 2 diabetes, while MASH is a more severe form of MASLD and a leading cause of liver failure worldwide. Without effective treatment, MASH can progress to cirrhosis, liver failure, or even liver cancer or death. The DR10624-202 study aims to determine the optimal dose of DR10624 for treating MASLD/MASH. We are committed to advancing DR10624 as a potential therapeutic option for patients with these serious liver diseases."
About Doer Biologics
Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics") is a clinical-stage biopharmaceutical company focused on the discovery and development of multi-specific biotherapeutics based on multi-domain structures to address unmet medical needs in the fields of metabolic diseases and cancer.
Doer Biologics has developed multiple proprietary platform technologies, including xLONGylation®, MultipleBody®, AccuBody®, and SMART-VHHBody.
For more information about Doer Biologics, please visit www.doerbio.com.