Hanmi Pharmaceutical (128940) has completed the core treatment period of a global Phase 2 trial for efpeglucagon, a congenital hyperinsulinism (CHI) treatment it is developing as the world's first once-weekly formulation, and will present the research findings at a European conference.
The company said on the 4th that it will present Phase 2 trial data on efpeglucagon (HM15136), a treatment for congenital hyperinsulinism, at the 64th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE 2026) in Marseille, France, on the 8th-10th.
Efpeglucagon is a CHI treatment that Hanmi Pharmaceutical is developing as the world's first once-weekly formulation. Congenital hyperinsulinism is a rare disease in which excessive insulin secretion causes hypoglycemia, and no treatment has been approved by the U.S. Food and Drug Administration for the condition as a specific indication.
Existing therapies used to manage hypoglycemia caused by hyperinsulinism work only in patients with certain genotypes and carry known side effects including excessive hair growth, fluid retention and heart failure. As a result, some patients turn to off-label drugs or undergo surgery to remove part of the pancreas.
According to results Hanmi Pharmaceutical presented at ESPE last year, efpeglucagon demonstrated safety and tolerability in CHI patients and reduced the incidence of hypoglycemia and severe hypoglycemia.
The FDA granted efpeglucagon breakthrough therapy designation (BTD) in February. BTD is a program that supports the development and approval of drugs showing potential for substantial improvement over existing treatments in serious conditions, offering benefits such as intensive FDA guidance and rolling review.
Efpeglucagon has received orphan drug designation from the FDA, the European Medicines Agency and South Korea's Ministry of Food and Drug Safety, and has also been granted rare pediatric disease designation by the FDA.
"We have completed the core treatment period of the global Phase 2 trial for efpeglucagon," said Lee Moon-hee, head of Hanmi Pharmaceutical's clinical development team. "In this oral presentation, we plan to present the demographic and clinical characteristics of the patients enrolled in the Phase 2 trial."
