Rezolute Announces Completion of Enrollment in the Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism

Core Insights - Enrollment in the sunRIZE study has been completed with 62 participants, surpassing the initial target of 56, including approximately 15% from U.S. sites [1][4] - Topline data from the study is expected to be released in December 2025, with a potential Biologics License Application submission to the FDA anticipated in 2026 if data supports it [2][4] Group 1: Study Details - The sunRIZE study is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial aimed at evaluating the efficacy and safety of ersodetug for treating congenital hyperinsulinism (HI) in patients aged 3 months to 45 years [3][4] - Participants are randomized into three treatment arms to receive either ersodetug (5 or 10 mg/kg) or a matched placebo, administered bi-weekly during an initial loading phase, followed by every four weeks for six months [3][4] - The primary and key secondary efficacy endpoints include the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia over the treatment period [4] Group 2: Product Information - Ersodetug is a fully human IgG2 monoclonal antibody that binds allosterically to the insulin receptor, aiming to reduce receptor over-activation by insulin and related substances, thereby improving hypoglycemia [5][6] - The therapy is designed to treat all forms of hyperinsulinism and has shown substantial benefits in clinical trials and real-world applications for both congenital and tumor-related HI [6]