Doer Biologics Starts Phase 2 Trial of DR10624 for Liver Disease Treatment with First Patient Dosed

HANGZHOU, China, April 22, 2025 -- Zhejiang Doer Biologics Co., Ltd., known as Doer Bio, has announced a significant milestone in the development of its innovative biotherapeutic, DR10624, by completing the initial patient dosing in a Phase 2 clinical trial. This trial focuses on evaluating DR10624, a pioneering tri-specific agonist, for its potential in treating metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). The drug targets three receptors: Fibroblast growth factor 21 receptor (FGF21R), Glucagon receptor (GCGR), and Glucagon-like peptide-1 receptor (GLP-1R).

The Phase 2 trial, designated DR10624-202, is a randomized, double-blind, placebo-controlled study. It aims to assess the safety and effectiveness of three different doses of DR10624 in adults at significant risk of liver fibrosis linked to MASLD. Key eligibility criteria for participants include a liver fat content of 10% or greater and liver stiffness between 8 and 15 Kpa, as determined by specialized imaging techniques. The trial plans to enroll 96 participants, with the primary outcome being the change in liver fat content percentage from the baseline after 12 weeks of treatment.

Dr. Yanshan Huang, the founder and CEO of Doer Bio, emphasized the unique attributes of DR10624, highlighting its development using the company's proprietary MultipleBody® platform technology. This technology allowed the creation of a long-acting tri-agonist with balanced activity targeting metabolic diseases. Preclinical studies showed DR10624's impressive efficacy in liver protection and lipid-lowering effects, which resulted in reduced steatosis, inflammation, and ballooning in relevant animal models.

The initiation of patient dosing in the DR10624 Phase 2 study marks a crucial step forward in developing treatments for MASLD and MASH. These conditions pose significant health risks, with MASLD increasing the likelihood of cardiovascular diseases and type 2 diabetes, and MASH being a major cause of liver failure worldwide. Without adequate treatment, MASH can advance to severe liver complications, including cirrhosis and liver cancer. Dr. Yongliang Fang, Chief Operating Officer of Doer Bio, expressed the company's commitment to advancing DR10624 as a viable treatment option for these serious liver diseases, aiming to identify the most effective dose through the current study.

Zhejiang Doer Biologics Co., Ltd., established as a clinical stage biopharmaceutical firm, focuses on discovering and developing multi-domain based multi-specific biotherapeutics, particularly targeting unmet medical needs in metabolic diseases and cancer treatment. The company's innovative approaches include several proprietary platform technologies such as xLONGylation®, MultipleBody®, AccuBody®, and SMART-VHHBody, which facilitate the development of novel therapeutics.

The advancement of DR10624 into Phase 2 clinical trials represents a significant achievement for Doer Bio in its mission to address critical health challenges associated with metabolic diseases. As the study progresses, the company continues to pioneer the development of new therapeutic options, potentially offering hope to patients suffering from debilitating liver conditions.