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

Core Insights - 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] - Enrollment for the trial is on track, expected to be completed by May 2025, with topline data anticipated in December 2025 [1][2] - The sunRIZE study is focused on evaluating the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), a condition that leads to poorly controlled hypoglycemia [4][5] Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company dedicated to developing therapies for rare diseases, particularly those with significant unmet medical needs [2][7] - The company's lead product, ersodetug, is a fully human monoclonal antibody designed to treat various forms of hyperinsulinism by decreasing insulin receptor over-activation [5][8] Study Details - The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial enrolling up to 56 participants aged 3 months to 45 years across more than a dozen countries [4] - The interim analysis conducted by the DMC evaluated the primary endpoint of hypoglycemia events after approximately half of the enrolled patients completed their assessments [3][4] Condition Background - Congenital hyperinsulinism is the most common cause of recurrent hypoglycemia in children, often presenting within the first month of life and can lead to severe complications if not managed properly [6] - More than half of children with congenital HI require long-term medical treatment, highlighting the need for effective therapies like ersodetug [6]