Core Insights - Rezolute, Inc. is focused on treating hypoglycemia caused by hyperinsulinism and has announced a late-breaking presentation at ENDO 2025 regarding its Phase 3 study of ersodetug [1][2] Group 1: 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 aged 3 months to 45 years with congenital hyperinsulinism [3] - The study aims to enroll approximately 56 participants across more than a dozen countries, including the U.S., and has completed enrollment [4] - Key efficacy endpoints include the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia over six months of treatment [4] Group 2: Drug Information - Ersodetug is a fully human IgG2 monoclonal antibody that binds allosterically to the insulin receptor, aiming to decrease receptor over-activation and improve hypoglycemia [5] - The drug has shown substantial benefit in clinical trials and real-world use for treating both congenital and tumor-related hyperinsulinism [7] Group 3: Medical Context - 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 hyperinsulinism require long-term medical treatment for hypoglycemia that is not adequately addressed by existing therapies [6]

Independent Data Monitoring Committee (the "DMC") recommends continuation of sunRIZE trial as planned with no need to increase sample size Enrollment on track and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. sites activated and enrolling patients About Ersodetug Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of HI, the ...