Rezolute Presents Positive Phase 3 sunRIZE Study Results for Ersodetug
Rezolute, Inc. announced expanded analyses from its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism, presented at the Pediatric Endocrine Society Annual Meeting. The data showed significant and consistent improvements in glycemic control across multiple CGM-based endpoints, despite the primary endpoint not achieving statistical significance. Preliminary observations from the open-label extension phase also demonstrated continued glycemic benefit, enabling a significant reduction in background standard of care therapies. Following a Type B meeting, the FDA acknowledged challenges with the primary endpoint and requested the submission of broader study data for comprehensive evaluation.
Key Highlights
- Ersodetug Phase 3 sunRIZE study showed significant, consistent glycemic control improvements.
- Average daily hypoglycemia time reduced >50% (FAS) and ~60-80% (PPS) by CGM.
- Average weekly hypoglycemia events reduced ~50-80% (FAS/PPS) by CGM.
- Average daily normoglycemia exposure increased ~25-50% (FAS/PPS) by CGM.
- Average blood glucose increased ~10-15% (~10-15 mg/dL) (FAS/PPS) by CGM.
- 57 of 59 study completers continue in open-label extension, showing sustained benefit.
- OLE participants significantly reduced/discontinued background standard of care therapies.
- FDA requested broader study data for comprehensive evaluation after Type B meeting.
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