Clinical TrialMay 1, 2026, 12:17 PM
RZLT Ersodetug Phase 3 sunRIZE Expanded Data Shows Glycemic Gains
AI Summary
Rezolute announced expanded analyses from its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism, presented at the Pediatric Endocrine Society 2026 Annual Meeting. The data showed significant and consistent improvements in glycemic control across multiple CGM-based endpoints, including over 50% reduction in hypoglycemia time and events. Preliminary observations from the open-label extension phase also indicate continued glycemic benefits, allowing for significant reduction in standard of care therapies. The company discussed these results with the FDA, which acknowledged challenges with the primary endpoint and requested broader study data for evaluation.
Key Highlights
- Ersodetug showed >50% reduction in daily hypoglycemia time (FAS) and ~60-80% (PPS) vs. placebo.
- Weekly hypoglycemia events reduced by ~50-65% (FAS) and ~50-80% (PPS) vs. placebo.
- Exposure to normoglycemia (AUC 70-180 mg/dL) increased by ~25-50% (FAS/PPS) vs. placebo.
- Average blood glucose increased by ~10-15 mg/dL (FAS/PPS) vs. placebo.
- All 59 study completers entered the open-label extension; 57 continue treatment for 6-24 months.
- FDA acknowledged primary endpoint challenges and requested broader study data for ersodetug.
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