Doer Biologics Hosts Protocol Meeting for Phase II DR10624-202 Trial in Metabolic Dysfunction-Associated Steatotic Liver Disease with High Fibrosis Risk
Doer Biologics
Biological Drug Developer
On December 15, 2024, the protocol discussion meeting for the Phase II randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of DR10624 injection in subjects with metabolic dysfunction-associated steatohepatitis (MASH) at high risk of liver fibrosis was successfully held in Shanghai. The trial is sponsored by Zhejiang Doer Biologics Co., Ltd. and led by Professor Junping Shi from the Affiliated Hospital of Hangzhou Normal University and Professor Wai-Sun Wong from Prince of Wales Hospital (Hong Kong).
The symposium on this program was chaired by Professor Shi Junping, Dean of the Medical Department of Hangzhou Normal University and Executive Vice President of the Affiliated Hospital of Hangzhou Normal University. Attendees included Professor Xie Wen from Beijing Ditan Hospital affiliated with Capital Medical University, Professor Zhang Jing from Beijing You'an Hospital affiliated with Capital Medical University, Professor Li Jie from Drum Tower Hospital affiliated with Nanjing University Medical School, Professor Zheng Minghua from the First Affiliated Hospital of Wenzhou Medical University, Professor Ye Hua from Ningbo Medical Center Lihuili Hospital, Professor Yang Hongju from the First Affiliated Hospital of Kunming Medical University, Professor Guo Qing from Ruijin Hospital affiliated with Shanghai Jiao Tong University, Professor Gong Ling from the Affiliated Hospital of Hangzhou Normal University, Professor Liu Jing from the Affiliated Hospital of Hangzhou Normal University, and Professor Chen Yue from Union Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology. Representatives from the sponsor team led by Dr. Huang Yanshan, founder and chairman of Zhejiang Doer Biologics Co., Ltd., and Dr. Xu Junfang, Chief Medical Officer of Huadong Medicine Co., Ltd., also participated in the discussion.
At the seminar, Dr. Yongliang Fang, COO of Doer Biologics, introduced the molecular design concept of DR10624 and the progress of the global multicenter Phase I clinical study (including a 1b/2a study with 12 weeks of continuous dosing) conducted in New Zealand and China to the participating experts. The recently unblinded clinical data demonstrated DR10624's remarkable efficacy in reducing triglycerides, lowering LDL cholesterol, decreasing total cholesterol, alleviating insulin resistance, eliminating liver fat, and achieving weight loss. The preliminary clinical data suggests that DR10624 has the potential to become a best-in-class (BIC) drug for improving human metabolism.
Subsequently, the attending experts conducted a thorough discussion on key eligibility criteria, endpoint indicators, examination methods, imaging and ultrasound detection platforms, and other comprehensive issues related to the clinical protocol. The experts provided valuable feedback on the design of the clinical protocol and the feasibility of clinical operations, reaching consensus on multiple critical clinical aspects. The meeting was successfully concluded.
DR10624-202 Study (A Phase II Clinical Study of DR10624 Injection for the Treatment of Metabolic Associated Fatty Liver Disease with High-Risk Liver Fibrosis) is the second Phase II clinical study initiated by Doer Biologics for the DR10624 product, following the DR10624-201 Study (A Phase II Clinical Study of DR10624 Injection for the Treatment of Severe Hypertriglyceridemia), marking a new journey in which DR10624 has fully embarked on clinical research for the treatment of multiple metabolic field diseases.
About Doer Biologics
Zhejiang Doer Biologics Co., Ltd. was established on April 1, 2014, with a registered capital of 52.12 million yuan. It is a high-tech enterprise under Huadong Medicine (Stock Code: SZ.000963) specializing in the development of innovative biopharmaceuticals. The company's R&D center is located in Hangzhou Medicine Port Town. Doer Biologics focuses on developing multi-specific innovative protein drugs based on multi-domain structures to address unmet clinical needs in metabolic diseases, cancer, and other fields. Currently, the company has five globally innovative products entering clinical research both in China and internationally. Additionally, the company has filed more than 60 domestic and international patent applications and is recognized as a National High-Tech Enterprise.