Hanmi Pharmaceutical has moved to expand the diabetes indication for its self-developed glucagon-like peptide-1 (GLP-1) class novel drug "Efpeglenatide."
Hanmi Pharmaceutical said on the 18th that it began the first patient dosing in a domestic phase 3 clinical trial evaluating the efficacy and safety of combination therapy with Efpeglenatide, metformin (Metformin), and the SGLT-2 inhibitor dapagliflozin (Dapagliflozin) in patients with type 2 diabetes.
Efpeglenatide is a GLP-1 class novel drug that applies Hanmi Pharmaceutical's proprietary platform technology "LAPSCOVERY." In Dec. last year, the company completed a marketing authorization application to the Ministery of Food and Drug Safety for the "obesity" indication and is awaiting approval, while also accelerating clinical work to broaden the scope of treatment.
The objective of this trial is to evaluate, in domestic patients with type 2 diabetes whose blood sugar control remains insufficient despite combination therapy with metformin and dapagliflozin, the blood sugar control effect and safety of the combination versus placebo. The trial is expected to conclude in 2028.
Earlier, Hanmi Pharmaceutical and its global partner conducted global clinical development in about 6,000 patients with type 2 diabetes. The company said Efpeglenatide demonstrated not only weight loss and blood sugar control effects but also potential cardiovascular and renal protection. The related study results were published in the New England Journal of Medicine (NEJM) and Circulation.
The company is also pursuing an LCM (Life Cycle Management) strategy to expand the use of Efpeglenatide. Along with indication expansion, it is reviewing formulation development to improve dosing convenience, such as an auto injector (Auto Injector) and a prefilled syringe (PFS), as well as a model linked to digital therapeutics (DTx).
Kim Na-young, head of innovation growth at Hanmi Pharmaceutical, said, "Efpeglenatide is an innovative new drug with potential to expand into various metabolic disease areas, including obesity and diabetes, and cardiovascular and renal diseases," adding, "Through this phase 3 combination study, we will prove its blood sugar control effect and continue to build clinical evidence as an integrated metabolic disease treatment."