Rezolute Announces Positive Recommendation After Independent Interim Analysis of Phase 3 sunRIZE Study of Ersodetug in Congenital Hyperinsulinism ("HI")

Core Viewpoint - The Independent Data Monitoring Committee (DMC) has recommended the continuation of the Phase 3 sunRIZE trial without increasing the sample size, indicating confidence in the study's design and initial assumptions [1][2][3] Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing therapies for rare diseases, particularly congenital hyperinsulinism (HI) [2][7] - The company's lead product, ersodetug, is a fully human monoclonal antibody aimed at treating hypoglycemia caused by HI [5][8] Study Details - The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ersodetug in patients with congenital HI [4] - The study is expected to enroll up to 56 participants aged 3 months to 45 years across more than a dozen countries, with enrollment anticipated to be completed by May 2025 [4][1] Clinical Insights - The DMC's interim analysis was based on a pre-specified evaluation of hypoglycemia events after approximately half of the enrolled patients completed primary assessments, confirming no need for a sample size increase [3] - The topline data from the study is expected to be announced in December 2025, with U.S. clinical sites actively enrolling patients [1][3] Treatment Potential - Ersodetug has the potential to be a best-in-class treatment option for individuals living with hyperinsulinism, as it acts downstream from the pancreas to improve hypoglycemia [5][3] - Congenital HI is a significant cause of recurrent hypoglycemia in children, and effective treatment options are limited, highlighting the importance of the ongoing study [6]