Handok Affiliate Resolute Reaches Agreement with FDA to Streamline Phase 3 Trial for Hyperinsulinism Treatment

On September 2 (local time), Resolute, an affiliate of Handok, announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) to significantly streamline the clinical development pathway for the Phase 3 clinical trial (upLIFT) of RZ358 (Ersodetug), a treatment for hypoglycemia caused by tumor-mediated hyperinsulinism (HI).

Under this agreement, the previous double-blind, randomized, placebo-controlled trial will be omitted, and a simplified clinical trial will be conducted with a single-arm, open-label design involving a minimum of 16 patients. This aligns with the patient recruitment strategy that Resolute is currently focusing on. In addition, the FDA confirmed that the results of Resolute's pivotal study 'sunRIZE' for congenital hyperinsulinism, which is scheduled for major results announcement in December this year, could serve as clinical evidence demonstrating the broad applicability of RZ358 (Ersodetug) for various forms of hyperinsulinism.

Nevan Charles Elam, Chief Executive Officer and founder of Resolute, stated, "The FDA's new leadership has been very proactive in expressing its commitment to responsibly simplifying clinical development for rare diseases where real clinical benefit and mechanistic validity have been demonstrated. This agreement is a model case of such an innovative approach and is based on positive results from administering Ersodetug to more than 10 patients with tumor-mediated hyperinsulinism through the expanded access program over the past two years."

Brian Roberts, Chief Medical Officer of Resolute, said, "The streamlined design of the upLIFT clinical trial is highly significant for patients suffering from severe hypoglycemia due to tumor-mediated hyperinsulinism, as well as for their families and healthcare professionals. We will focus on the upLIFT clinical trial and leverage our strong clinical foundation in congenital hyperinsulinism to develop and deliver the treatment quickly and efficiently."

Meanwhile, Resolute is a U.S. bioventure company 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 rights to commercialize RZ358 and RZ402 in Korea and is continuously collaborating with Resolute on their development stages.

This content was produced with the assistance of AI translation services.