Rezolute Says Phase 3 SunRIZE Study Fails To Meet Primary, Secondary Endpoints

(RTTNews) - Rezolute, Inc. (RZLT), a rare disease company, announced Thursday 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.

The Phase 3 upLIFT study for tumor HI is ongoing with topline results expected in the second half of 2026.