Rezolute provides update on Phase 3 sunRIZE study on ersodetug

Rezolute (RZLT) announced outcomes from an independent Data Monitoring Committee, DMC, review of the open label arm, OLA, portion of the sunRIZE Phase 3 study of ersodetug for the treatment of hypoglycemia due to congenital hyperinsulinism and provided additional study updates including guidance on its upcoming interim analysis by the DMC. This IA will assess the adequacy of the sample size for the primary endpoint and may recommend adjustments if necessary. Findings from the DMC include the following: Ersodetug was generally safe and well-tolerated in participants 3 months to 1 year of age. Observed ersodetug drug levels at peak and trough were comparable to exposures in older pediatric participants in the Phase 2b RIZE study, which were demonstrated to be effective. Safety and exposures validate the chosen dose regimen of 5 and 10 mg/kg administered bi-weekly and monthly. Subsequent infant participants may now be enrolled into the double-blind, placebo-controlled study. sunRIZE enrollment completion expected in Q2 2025, subject to outcomes from upcoming interim analysis