Hanmi Pharmaceutical Presents Phase 2 Study of Treatment for Congenital Hyperinsulinism

[Financial News] 
Hanmi Pharmaceutical has completed the core dosing period of a global Phase 2 trial of efpegerglucagon (HM15136), a treatment for congenital hyperinsulinism being developed as the world's first once-weekly formulation.
 Hanmi Pharmaceutical announced on the 6th that it will give an oral presentation on the Phase 2 study 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 to treat congenital hyperinsulinism, a rare disease in which excessive insulin secretion causes hypoglycemia. Hanmi Pharmaceutical is developing it as the world's first once-weekly formulation to overcome the limitations of existing treatment methods.
 To date, no treatment specifically indicated for congenital hyperinsulinism has been approved by the U.S. Food and Drug Administration (FDA). Existing treatments approved to control hypoglycemia caused by hyperinsulinism have shown responses limited to certain genotypes and are associated with side effects such as hypertrichosis, fluid retention, and heart failure.
 As a result, many patients use off-label medicines or rely on pancreatectomy while accepting the risk of side effects.
 According to findings Hanmi Pharmaceutical presented at the European Society for Paediatric Endocrinology last year, efpegerglucagon demonstrated safety and tolerability in patients with congenital hyperinsulinism and reduced both hypoglycemia and severe hypoglycemia.
 Efpegerglucagon was granted breakthrough therapy designation (BTD) by the FDA in February this year. The FDA's BTD program is designed to expedite the development and approval of medicines for serious conditions when early clinical evidence indicates the potential for substantial clinical improvement over existing treatments.
 Treatments granted BTD can receive intensive advice and support from the FDA throughout development, from clinical trials through approval. They may also be eligible for accelerated review programs, including rolling review, in which application materials are submitted and reviewed in stages, and priority review.
 Efpegerglucagon has received orphan-drug designation as a treatment for congenital hyperinsulinism from the FDA, the European Medicines Agency (EMA), and South Korea's Ministry of Food and Drug Safety. The FDA has also designated it as a treatment for a rare pediatric disease, while the EMA has designated it as an orphan medicine for the treatment of insulin autoimmune syndrome.
 Lee Moon-hee, Hanmi Pharmaceutical's clinical team leader and executive director, said, "We have completed the core dosing period of the global Phase 2 trial of efpegerglucagon." He added, "At the oral presentation, we will present the demographic and clinical characteristics of patients who participated in the Phase 2 trial."
[email protected] Jung Sang-hee Reporter