Resolute, an Affiliate of Handok, Receives FDA Breakthrough Therapy Designation for RZ358

On May 5 (local time), Resolute, an affiliate of Handok, announced that its treatment for hypoglycemia caused by tumor-mediated hyperinsulinism, RZ358 (Ersodetug), has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA).

The Breakthrough Therapy Designation for RZ358 (Ersodetug) was granted based on clinical data, the drug’s mechanistic potential to act on tumor-mediated hyperinsulinism, and meaningful effects observed in actual patient treatment through the Expanded Access Program currently underway across the United States. The Breakthrough Therapy Designation is a system designed to accelerate the development and review process for drugs that show significantly meaningful effects in early clinical stages compared to existing therapies for serious or life-threatening diseases.

Nevan Charles Elam, CEO and founder of Resolute, stated, "This Breakthrough Therapy Designation is an official recognition by the FDA of the therapeutic potential that Ersodetug can offer for life-threatening diseases. Ersodetug can provide therapeutic benefits in cases where persistent hypoglycemia is difficult to effectively control with standard therapies, or when hypoglycemia interferes with surgery or other tumor treatments." He added, "Ersodetug has a unique mechanism that can act on various forms of hyperinsulinism, and over the past two years, we have confirmed successful treatment effects in patients with tumor-mediated hyperinsulinism."

Resolute plans to initiate a registrational study of RZ358 (Ersodetug) for patients with tumor-mediated hyperinsulinism in the middle of this year. The company expects to announce topline (summary) data in the second half of next year. At the same time, based on this Breakthrough Therapy Designation, Resolute will discuss with the FDA the preparation of materials for submitting a Biologics License Application (BLA) for the indication of tumor-mediated hyperinsulinism for RZ358 (Ersodetug).

Earlier this year, Resolute also received Breakthrough Therapy Designation for RZ358 (Ersodetug) for the treatment of hypoglycemia caused by congenital hyperinsulinism. For this indication, global Phase 3 clinical trials are currently underway in more than 12 countries worldwide.

Meanwhile, Resolute is a U.S. bioventure developing targeted therapies for rare and metabolic diseases, including RZ358 for hyperinsulinism and RZ402, an oral treatment for diabetic macular edema. Among these, RZ358 is undergoing Phase 3 clinical trials for two indications: congenital hyperinsulinism and tumor-mediated hyperinsulinism. Handok holds the commercialization rights for RZ358 and RZ402 in Korea and continues to collaborate with Resolute on their development stages.