Handok “hyperinsulinism treatment developed by affiliate company designated as innovative treatment by FDA”

Resolute, a Korean-German affiliate, announced on the 7th (local time) that its drug ‘RZ358 (Ersodetug)’, a treatment for hypoglycemia caused by congenital hyperinsulinism (HI), has been designated as an innovative treatment by the U.S. Food and Drug Administration (FDA). Innovative treatment designation is a system that supports the rapid development and approval of new drug candidates that show significantly improved treatment effects compared to existing treatments for serious or life-threatening diseases.

This innovative treatment designation is based on the results of a phase 2b clinical trial targeting patients with congenital hyperinsulinism. As a result of the study, hypoglycemia was improved in more than 75% of patients, and no clinically significant hyperglycemia occurred.

Rezolute is conducting phase 3 clinical trials of Ersodetug for two indications: congenital hyperinsulinism and tumor-mediated hyperinsulinism. Congenital hyperinsulinism is undergoing global phase 3 clinical trials, including in the United States, and topline results are scheduled to be announced in the second half of this year. Additionally, with the goal of treating hypoglycemia caused by tumor-mediated hyperinsulinism last year, phase 3 clinical trials will begin in the first half of this year and major clinical results will be announced in the second half of next year.

Nevan Charles, CEO and founder of Ilam Resolute, said, “With this breakthrough therapy designation, Ersodetug has been recognized for its potential to provide therapeutic benefits to patients with hyperinsulinism.” “We plan to complete phase 3 patient recruitment and announce topline results, and we will also conduct phase 3 clinical research on tumor-mediated hyperinsulinism.”

Resolute is an American bio venture that develops targeted treatments for rare and metabolic diseases. We are developing ‘RZ358’, a treatment for congenital hyperinsulinism, and ‘RZ402’, an oral diabetic macular edema treatment. Handok holds the commercialization rights for ‘RZ358’ and ‘RZ402’ in Korea and continues to cooperate with Resolute in the development stage.