Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism

Core Insights - The company believes that data from the sunRIZE study and the Expanded Access Program (EAP) provide evidence of the activity of ersodetug in treating hypoglycemia caused by hyperinsulinism (HI) [1][2] - The company plans to meet with the FDA to discuss the path forward for congenital HI treatment [1][8] Summary by Sections Congenital HI - The sunRIZE study did not meet its primary or key secondary endpoints, but the company believes the overall data supports the pharmacologic activity of ersodetug against hypoglycemia [2][4] - Target therapeutic drug concentrations were achieved in both treatment groups (5 mg/kg and 10 mg/kg), with significant biomarker responses indicating reduced insulin activity [2][4] - The study showed reductions in hypoglycemia events and time in hypoglycemia, but these were not statistically significant compared to the placebo group [4][5] - The company is exploring how to characterize the study dynamics, including patient-reported quality of life outcomes [5] Ongoing Studies - All 59 participants who completed the sunRIZE study chose to continue receiving ersodetug in the open-label extension (OLE) phase, with 57 participants remaining [7] - Some children in the OLE have stopped all other therapies and are now on ersodetug monotherapy, which the company views as a potential indicator of efficacy [7] Tumor HI - Over the past two years, the company has provided ersodetug to over a dozen patients with severe hypoglycemia due to tumor HI, reporting substantial improvements and well-tolerated therapy [9][10] - In the EAP, 75% of patients receiving IV dextrose/total parenteral nutrition (TPN) achieved complete discontinuation of these treatments [10] - The ongoing upLIFT study will assess the primary endpoint of the glucose infusion rate (GIR), with topline results expected in the second half of 2026 [11] About Ersodetug - Ersodetug is a fully human monoclonal antibody designed to decrease insulin receptor over-activation, potentially effective for all forms of HI [15] About Rezolute, Inc. - Rezolute is focused on treating hypoglycemia caused by HI, with ersodetug being studied for both congenital and tumor HI [16]