India, Feb. 5 -- Rezolute, Inc. (RZLT), a late-stage biopharmaceutical company focused on rare diseases, provided an update on its Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital hyperinsulinism or HI.
The open-label arm of the study, which enrolled 8 infant participants aged 3 months to 1 year, has been reviewed by an independent Data Monitoring Committee or DMC.
The review confirmed that ersodetug was well-tolerated and reached the target drug concentrations at the tested doses of 5 and 10 mg/kg.
Based on these findings, the DMC has approved the enrollment of infants into the double-blind portion of the study.
The trial is on track for enrollment completion in Q2 2025, pending recommendations fro...