Rezolute Announces Oral Presentation of Results From its Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism at the Pediatric Endocrine Society Annual Meeting
Rezolute presented expanded Phase 3 data showing ersodetug improved glycemic control on CGM measures, despite the sunRIZE study missing its primary endpoint. Following a Type B meeting, the FDA acknowledged issues with the primary endpoint and requested the broader study dataset to determine the next steps for the program. Detailed analyses revealed clinically relevant reductions in hypoglycemia events of 50-80% and increases in time in normoglycemia compared to placebo. All 59 study completers entered the open-label extension, with 57 remaining and showing sustained benefit, including a significant reduction in the use of background standard of care therapies.
Key figures
- Drug Name
- ersodetug
- Phase Of Trial
- Phase 3
- Fda meeting date
- March 17, 2026
- Blood glucose increase
- ~10-15 mg/dL
- Exposure duration months
- 6 to 24
- Ole participants initial
- 59
- Total study participants
- 63
- Ole participants remaining
- 57
- Normoglycemia increase fas pps
- ~25-50%
- Hypoglycemia event reduction fas
- >50%
- Hypoglycemia event reduction pps
- ~60-80%
AI analysis
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