Handok's Affiliate Rezolute Advances Development of Congenital Hyperinsulinism Treatment (RZ358), Confirming Safety and Proceeding with Phase 3 Trials in the U.S. Without Age Restrictions

  • 2024.09.10
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Handok's Affiliate Rezolute Advances Development of Congenital Hyperinsulinism Treatment (RZ358), Confirming Safety and Proceeding with Phase 3 Trials in the U.S. Without Age Restrictions
 
Handok's affiliate Rezolute announced on September 9 (U.S. time) that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on RZ358, a treatment for hypoglycemia due to congenital hyperinsulinism (HI), and approved the inclusion of the U.S. in the ongoing global Phase 3 trial.

RZ358 (Ersodetug) is currently in the Phase 3 stage of the sunRIZE trial, targeting patients with congenital hyperinsulinism. The sunRIZE trial is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of RZ358. With this approval, Rezolute will begin enrolling U.S. patients in the global sunRIZE study. Patient enrollment in the U.S. is expected to start in early 2025, with topline results anticipated by the second half of 2025.

Nevan Charles Elam, CEO and founder of Rezolute, stated, "We are very pleased that the FDA has fully lifted the partial clinical hold and allowed us to proceed with the study in the U.S. at all doses, including participants for more than three months. The FDA concluded that the liver toxicity observed in Sprague-Dawley rats is species-specific and not relevant to humans." He added, "This follows the recent approval of our global Phase 3 trial for tumor-induced hyperinsulinism, allowing us to conduct two rare disease programs at the global Phase 3 stage, including the U.S."

RZ358, developed by Rezolute, is a monoclonal antibody that acts on a specific site of the insulin receptor. It is being evaluated for its therapeutic effects on various conditions characterized by excessive insulin, including congenital hyperinsulinism, pancreatic islet cell tumor hypoglycemia, and non-islet cell tumor hypoglycemia, with additional indications under consideration.

Rezolute is a bioventure focused on developing targeted therapies for rare and metabolic diseases. It is developing 'RZ358' for congenital hyperinsulinism and 'RZ402' for oral treatment of diabetic macular edema. Handok holds the commercialization rights for 'RZ358' and 'RZ402' in Korea.
 
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