Doer Biologics Announces First Subject Dosed in Phase I 12-Week Multiple-Ascending Dose (MAD) Clinical Trial of DR10624 and Received IND Approval From NMPA

HANGZHOU, China, Aug. 1, 2023 /PRNewswire/ — 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 Glucagon-like peptide-1 receptor (GLP-1R), Glucagon receptor (GCGR), and Fibroblast growth factor 21 receptor (FGF21R), has completed the dosing of the first subject in the Phase Ib 12-week Multiple-Ascending Dose (MAD) study of DR10624 for the treatment of obesity and hypertriglyceridemia in New Zealand. 

The Phase I MAD study is a randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DR10624 in adult obese subjects with moderate hypertriglyceridemia.  The study will evaluate the safety and efficacy of DR10624 treatment across multiple different dose levels. The participating subject will receive a subcutaneous injection of DR10624 or placebo for 12 weeks.

Doer Bio also announces that it has recently received the IND approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for DR10624 for the treatment of obesity in China.

“DR10624 is a novel FIC tri-specific biotherapeutic that specifically agonizing GLP-1R, glucagon receptor GCGR, and FGF21R. Utilizing Doer Bio’s proprietary MultipleBody® platform technology, DR10624 is designed and engineered to exhibit balanced activity for metabolic diseases. In various preclinical studies, DR10624 consistently demonstrated weight reduction, glucose lowering, metabolic improvement, and liver function improvement.” said Yanshan Huang, Ph.D., founder and Chief Executive Officer of Doer Bio.

“We are encouraged by the progress of the ongoing Phase I single ascending dose (SAD) study of DR10624 in New Zealand. The dosing of the first subject in the 12-week MAD study and IND approval from NMPA mark an important milestone in our clinical translation of DR10624. There is a growing unmet medical need for patients suffering from metabolic dysfunction. We look forward to developing DR10624 as a potential treatment for those patients in need”. commented Yongliang Fang, Ph.D., Chief Operating Officer of Doer Bio.

More information about the MAD clinical trial is available at clinicaltrials.gov (NCT05378893)

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®, MultiBody®, AccuBody®, and SMART-VHHBody.

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

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