Hanmi Pharmaceutical completes Phase 2 dosing for CHI treatment

Hanmi Pharmaceutical has completed the core dosing period of its global Phase 2 clinical trial for Epegaglucagon, a candidate treatment for congenital hyperinsulinism (CHI). The company plans to present the demographic and clinical characteristics of the trial participants at the 64th European Society for Paediatric Endocrinology (ESPE 2026) meeting in Marseille, France.

Epegaglucagon is being developed as a once-weekly subcutaneous injection, aiming to provide a more convenient alternative to existing treatments or continuous infusion devices. CHI is a rare disease characterized by excessive insulin secretion, leading to persistent hypoglycemia. Currently, no treatment specifically approved by the FDA for CHI exists.

The global Phase 2 'ACHIEVE' study involves 16 patients aged two and older across five countries, including South Korea, the United States, Germany, Israel, and the United Kingdom. Previous interim data indicated that Epegaglucagon could reduce the frequency of hypoglycemic events. The candidate has already received Breakthrough Therapy Designation from the FDA and has been designated as an orphan drug by the FDA, the European Medicines Agency, and South Korea’s Ministry of Food and Drug Safety.