Hanmi Pharmaceutical will present details of its global Phase 2 clinical trial of efpeglenatide (HM15136), an investigational treatment for congenital hyperinsulinism, at a European medical conference.
Hanmi Pharmaceutical said Sept. 4 that it will give an oral presentation on the Phase 2 study of efpeglenatide at the 64th European Society for Paediatric Endocrinology (ESPE 2026) meeting, which will be held in Marseille, France, from Sept. 8 to 10.
Efpeglenatide is being developed to treat congenital hyperinsulinism, a rare disease in which excessive insulin secretion causes hypoglycemia. Hanmi Pharmaceutical is developing the drug as the world’s first once-weekly formulation to address limitations of existing treatments.
Congenital hyperinsulinism is a rare disease that can cause severe hypoglycemia in infants and young children. Currently, the U.S. Food and Drug Administration (FDA) has not approved any treatment specifically for congenital hyperinsulinism. Treatments currently used to control hypoglycemia caused by hyperinsulinism have also shown limited efficacy in some genotypes and have been associated with side effects including excessive hair growth, fluid retention and heart failure.
Hanmi Pharmaceutical has completed the key dosing period of its global Phase 2 trial of efpeglenatide and is analyzing the clinical data. At the conference, the company plans to present demographic and clinical characteristics of patients who participated in the Phase 2 trial.
Clinical results presented at last year’s European Society for Paediatric Endocrinology meeting showed that efpeglenatide had a favorable safety and tolerability profile in patients with congenital hyperinsulinism and was effective in reducing the occurrence of hypoglycemia and severe hypoglycemia.
Efpeglenatide was designated a breakthrough therapy by the FDA in February this year. The breakthrough therapy designation is a program that supports the development and review of candidates for serious diseases when preliminary clinical evidence indicates substantial improvement over existing treatments.
The drug has also received orphan drug designations for the treatment of congenital hyperinsulinism from the FDA, the European Medicines Agency (EMA) and South Korea’s Ministry of Food and Drug Safety. The FDA has additionally designated it as a treatment for a pediatric rare disease.
Lee Moon-hee, senior vice president and head of the clinical team, said, “We have completed the key dosing period of the global Phase 2 clinical trial of efpeglenatide. In this oral presentation, we plan to present the demographic and clinical characteristics of the patients who participated in the Phase 2 trial.”
Hanmi Pharmaceutical, a South Korean pharmaceutical company founded in 1973, has expanded its prescription drug and new drug development businesses based on its in-house research and development (R&D) capabilities. After establishing a domestic business base centered on improved and combination drugs, the company expanded its research into biologic drugs and built a diverse new drug pipeline in areas including obesity and metabolic diseases and rare diseases based on Labscovery, its long-acting biologics platform technology.
