FDA Lifts Partial Clinical Holds on RZ358 for the Treatment of Congenital Hyperinsulinism and Authorizes U.S. Inclusion in Ongoing Phase 3 Study

Core Viewpoint - Rezolute, Inc. has announced the removal of partial clinical holds by the FDA on RZ358 (ersodetug), a therapy for hypoglycemia caused by congenital hyperinsulinism, allowing the company to proceed with its clinical studies in the U.S. [1][3] Group 1: Clinical Development - Ersodetug is currently being studied in the sunRIZE Phase 3 trial, which is a global, multi-center, double-blind, randomized, placebo-controlled study aimed at evaluating its safety and efficacy in patients with congenital hyperinsulinism [2][5] - The company plans to initiate study start-up activities in the U.S. and expects U.S. enrollment to begin in early 2025, with topline data anticipated in the second half of 2025 [2][3] Group 2: Drug Mechanism and Target Population - Ersodetug is a fully human monoclonal antibody that targets insulin receptors to mitigate the effects of insulin receptor over-activation, thereby improving hypoglycemia in hyperinsulinism conditions [4] - The sunRIZE study will enroll participants aged between 3 months and 45 years, with a target of up to 56 participants across more than a dozen countries [5]