Core Viewpoint - Rezolute, Inc. has announced positive outcomes from the Data Monitoring Committee (DMC) review of the open-label arm of the sunRIZE Phase 3 study for ersodetug, indicating safety and allowing enrollment of infants into the double-blind portion of the study [1][3] Group 1: Study Updates - The open-label arm included 8 infant participants aged 3 months to 1 year, who received doses of 5 or 10 mg/kg of ersodetug [2] - The DMC confirmed the safety and pharmacokinetics of ersodetug, validating the chosen dose regimen and allowing for the continuation of the study [7] - Enrollment completion for the sunRIZE study is expected in Q2 2025, with topline results anticipated in Q4 2025, pending the outcomes of an upcoming interim analysis [1][3] Group 2: Interim Analysis - An interim analysis will assess the adequacy of the sample size for the primary endpoint and may recommend adjustments, including a potential increase in sample size by 33% [4][5] - The DMC will announce the conclusions of the interim analysis early in Q2 2025, with three possible outcomes: stop the study for futility, continue as is, or increase the sample size [4] Group 3: Company Background and Product Information - Rezolute is focused on developing therapies for rare diseases, particularly congenital hyperinsulinism, which causes recurrent hypoglycemia in children [8][11] - Ersodetug is a fully human monoclonal antibody designed to counteract insulin receptor over-activation, potentially effective for various forms of hyperinsulinism [9][11] - The sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ersodetug in patients aged 3 months to 45 years [10]
Rezolute Provides Update on its Phase 3 sunRIZE Study of Ersodetug for the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism