Hanmi Pharmaceutical to Present Phase 2 Results for Rare-Disease Treatment ‘Efpegerglucagon’

[Financial News] Hanmi Pharmaceutical will present the findings of a Phase 2 clinical trial of efpegerglucagon (HM15136), a treatment being developed for congenital hyperinsulinism, a rare disease, at an international conference.
Hanmi Pharmaceutical announced on the 4th that it will give an oral presentation on the results of the global Phase 2 trial of efpegerglucagon at the 64th annual meeting of the European Society for Paediatric Endocrinology (ESPE 2026), which will be held in Marseille, France, from the 8th to the 10th.
Efpegerglucagon is being developed as a treatment for congenital hyperinsulinism, a condition in which excessive insulin secretion causes hypoglycemia. Hanmi Pharmaceutical is developing it as a once-weekly treatment to improve convenience for patients.
Congenital hyperinsulinism is a rare disease that primarily affects children. Repeated episodes of severe hypoglycemia can lead to neurological damage. Currently, no treatment has been approved by the U.S. Food and Drug Administration (FDA) for congenital hyperinsulinism.
Existing treatments for controlling hypoglycemia are effective only in some patients, and side effects such as hirsutism, fluid retention, and heart failure have been reported, limiting treatment options. As a result, some patients use medicines outside their approved indications or undergo surgery to remove part of the pancreas.
Hanmi Pharmaceutical presented initial clinical results for efpegerglucagon at the European Society for Paediatric Endocrinology meeting last year. The treatment was found to be safe and tolerable in patients with congenital hyperinsulinism, and it was observed to reduce the incidence of hypoglycemia and severe hypoglycemia.
Efpegerglucagon received Breakthrough Therapy Designation (BTD) from the FDA in February this year. BTD is a program that supports the development and review of candidates for serious diseases when they have shown potential for clinically meaningful improvement over existing treatments.
Efpegerglucagon has received orphan-drug designation for the treatment of congenital hyperinsulinism from the FDA, the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety. The FDA has also designated it as a treatment for a rare pediatric disease.
Hanmi Pharmaceutical has completed the key dosing period of the global Phase 2 trial and is currently analyzing the data.
Lee Moon-hee, executive director and head of Hanmi Pharmaceutical’s clinical team, said, "We have completed the key dosing period of the global Phase 2 trial of efpegerglucagon." Lee added, "At this conference, we plan to present the demographic and clinical characteristics of the patients who participated in the Phase 2 trial."

[email protected] Reporter Jung Sang-hee Reporter