Hanmi Pharmaceutical has begun dosing patients in a domestic Phase 3 clinical trial aimed at expanding the indication of its in-house developed glucagon-like peptide (GLP)-1 class new drug "efpeglenatide" from obesity to diabetes.
Hanmi Pharmaceutical said Tuesday that it began dosing the first patient on the 13th of last month in a Phase 3 clinical trial evaluating the blood sugar control effects of efpeglenatide in combination with metformin and dapagliflozin (an SGLT2 inhibitor) in patients with type 2 diabetes. Efpeglenatide is an obesity drug to which Hanmi Pharmaceutical's proprietary platform technology "LAPSCOVERY" has been applied.
The Phase 3 trial, approved by the Ministry of Food and Drug Safety in January this year, is designed to compare and evaluate the efficacy and safety of efpeglenatide versus placebo when administered in combination with metformin and dapagliflozin in patients whose blood sugar is not controlled by those two drugs. The trial will be conducted in domestic patients in a multicenter, randomized, double-blind, placebo-controlled format and is scheduled to conclude in 2028.
Hanmi Pharmaceutical views obesity not as a single disease but as a "complex metabolic disorder" that leads to type 2 diabetes and cardiovascular disease, and is pursuing a strategy to expand the application range of efpeglenatide. Based on prior global clinical experience involving approximately 6,000 type 2 diabetes patients conducted with a global partner, the company plans to swiftly push forward with expanding the diabetes indication. Along with the expansion of the diabetes indication, the company also plans to pursue diversification of formulations to improve patient dosing convenience and treatment accessibility.
"Efpeglenatide is an innovative new drug with the potential to expand its treatment area beyond obesity to various metabolic diseases including diabetes, cardiovascular disease, and kidney disease," said Kim Na-young, head of Hanmi Pharmaceutical's Innovation and Growth Division. "Through this Phase 3 combination trial, we will clearly demonstrate efpeglenatide's blood sugar control capability and continue to accumulate clinical evidence."
