Hanmi Pharmaceutical has started dosing patients in a Korean phase 3 trial of efpeglenatide for type 2 diabetes, adding a second late-stage path for the GLP-1 drug after filing it as an obesity treatment.
The study will test efpeglenatide in patients whose blood sugar is not controlled well enough with metformin and dapagliflozin, an SGLT-2 inhibitor.
Hanmi said the first patient was dosed on April 13. The trial is expected to finish in 2028.
Hanmi Pharmaceutical headquarters in Songpa-gu, Seoul (Courtesy of Hanmi Pharmaceutical)
The trial enters a market already shaped by imported GLP-1 drugs, including Novo Nordisk’s semaglutide brands Ozempic and Wegovy and Eli Lilly’s tirzepatide drug Mounjaro.
Hanmi is positioning efpeglenatide as a Korean alternative that could offer better access or price competitiveness than imported GLP-1 treatments, a company spokesperson told Korea Biomedical Review.
Efpeglenatide is a once-weekly GLP-1 receptor agonist using Hanmi’s LAPSCOVERY technology, a long-acting drug platform developed by the company.
Hanmi has described it as Korea’s first fully domestically developed GLP-1 drug.
The new phase 3 trial will compare efpeglenatide with placebo when added to metformin and dapagliflozin. It will be run at multiple Korean hospitals as a randomized, double-blind, placebo-controlled study.
The company spokesperson said Sanofi’s former global phase 3 diabetes program for efpeglenatide generated clinical data from about 6,000 patients with type 2 diabetes before the rights returned to Hanmi.
The diabetes trial gives Hanmi a way to use that earlier data in Korea, where the company is preparing efpeglenatide for obesity while building a broader metabolic disease program around the drug.
Kim Na-young, Hanmi’s senior managing director, said the company would use the new trial to build evidence for patients whose metabolic diseases often overlap.
“Efpeglenatide has the potential to expand beyond obesity into diabetes, cardiovascular and kidney disease, and other metabolic conditions,” Kim said. “Through this combination phase 3 trial, we will clearly demonstrate its blood sugar control and continue building clinical evidence for its role as an integrated metabolic disease treatment.”
Hanmi is also developing new delivery formats, including auto-injectors and prefilled syringes.
The company said it has also discussed combining the drug with digital therapeutics for obesity and metabolic disease management.
Kim Ji-hye
댓글
0