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Rezolute Announces Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism
Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40%
About this update from Rezolute, Inc.
[{"type":"text","content":"Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET REDWOOD CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI). The study did not meet its primary endpoint, which assessed change in the average weekly hypoglycemia events by self monitored blood glucose. There was an approximate 45% reduction in hypoglycemia events observed at the top ersodetug dose (10 mg/kg), which was not statistically significant compared to the placebo group, which experienced a 40% improvement. Furthermore, the study did not meet its key secondary endpoint, which assessed change in average daily percent time in hypoglycemia by continuous glucose monitoring (CGM). At the 10 mg/kg dose of ersodetug, an approximate 25% reduction in time in hypoglycemia was observed, which was not statistically significant compared to the placebo, which increased by approximately 5%. At the study dose regimens of 5 and 10 mg/kg administered every other week for 3 doses, followed by every 4 weeks over the remainder of the 24-week treatment duration, ersodetug target drug concentrations were achieved, across all age groups studied. Safety observations from the study were generally favorable and, in the opinion of the Company, support safe use of ersodetug in pediatric and adult patients. Two of the study participants experienced serious hypersensitivity reactions which led to early discontinuation of study drug. The incidence of serious allergic reactions across the program is relatively low compared to biologic or monoclonal antibody treatments. The most commonly reported study adverse event in ersodetug treated participants compared to placebo was hypertrichosis, which was generally mild and self-limiting. “We are disappointed that the study did not demonstrate significant improvements in glucose-related endpoints relative to placebo as well as for the patients and families living with congenital HI who urgently need new...