Rezolute Shows Over 50% Hypoglycemia Reduction in Phase 3 sunRIZE Data
Rezolute presented expanded sunRIZE Phase 3 data showing ersodetug reduced CGM-measured hypoglycemia time by over 50% (FAS) and up to 80% (PPS), and increased normoglycemia exposure by 25–50% versus placebo. Open-label extension reports retention of 57 of 59 patients with continued glycemic benefits and reduced standard-of-care therapies.
1. Expanded Phase 3 sunRIZE Data
Rezolute presented additional CGM-based endpoints from the sunRIZE study showing ersodetug decreased average daily hypoglycemia time by over 50% in the Full Analysis Set and 60–80% in the Per Protocol Set, reduced weekly hypoglycemia events by 50–80%, increased AUC 70–180 mg/dL by 25–50%, and raised average blood glucose by 10–15 mg/dL compared to placebo.
2. Open-Label Extension Outcomes
Following the controlled phase, 57 of 59 study completers entered the open-label extension and have received ersodetug for approximately 6 to 24 months, demonstrating sustained glycemic improvements that enabled significant reductions or discontinuation of diazoxide, somatostatin analogs, and tube feeds, with a notable number of patients now maintained on ersodetug monotherapy.
3. FDA Type B Meeting and Next Steps
In a March meeting with the FDA, the agency acknowledged challenges with the finger-stick primary endpoint and requested submission of the broader sunRIZE dataset for comprehensive evaluation, signaling regulator engagement on the expanded CGM-based analyses to inform the approval pathway.