other material
confidence high
sentiment positive
materiality 0.75
Rezolute completes Phase 2 DME enrollment, initiates Phase 3 for congenital hyperinsulinism
Rezolute, Inc.
- Phase 2 study of oral RZ402 for diabetic macular edema enrolled ~95 participants; topline data expected mid-Q2 2024.
- Phase 3 sunRIZE study of RZ358 for congenital hyperinsulinism initiated; first clinical site activated outside US.
- Phase 3 to enroll up to 56 patients at ~20 centers in >12 countries; topline results anticipated mid-2025.
- RZ358 previously received EMA PRIME designation in October 2023 for congenital hyperinsulinism.