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 from an upcoming interim analysis or IA, which will assess the sample size adequacy for the primary endpoint.
Topline results from the study are expected in Q4 2025.
Ersodetug, a monoclonal antibody targeting insulin receptor over-activation, shows promise as a universal treatment for hypoglycemia due to congenital or acquired HI, which is currently underserved by available therapies.
RZLT closed Tuesday's (FEB.04 2025) trading at $5.50 up by 4.96%.
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