Doer Biologics, a subsidiary of China-based Huadong Medicine, has received breakthrough therapy designation (BTD) from China's Centre for Drug Evaluation (CDE) for its first-in-class triple agonist DR10624, intended for the treatment of severe hypertriglyceridaemia. The drug is a long-acting molecule designed to simultaneously target the GLP-1, glucagon and FGF21 receptors. Results from a Phase II study demonstrated significant lipid-lowering effects, with a median reduction in fasting triglycerides of up to 74.5% after 12 weeks of treatment, compared to an 8.0% reduction in the placebo group.

The study also indicated broader metabolic benefits, including a rapid and substantial decrease in liver fat content by up to 67%, weight loss, and improvements in other atherogenic lipid parameters such as total cholesterol and HDL-C. In patients with baseline HbA1c at or above 6.5%, a reduction of 0.68% was observed. These comprehensive data support the drug's potential as a multifaceted therapy for severe metabolic disorders.

According to PharmCube's NextBiopharm® database, DR10624 is being developed in nine different conditions. Click here to request a free trial for NextBiopharm®.