Rezolute fully enrolls Phase 3 sunRIZE study of ersodetug; topline data expected by end of 2025

Rezolute, Inc.

63 participants enrolled (8 open-label infants, 55 double-blind); DMC recommended continuing with original sample size after interim analysis.
Baseline hypoglycemia burden severe: mean 15 events/week (SMBG), 19% time <70 mg/dL (CGM); 51% hospitalized in past year.
76% of participants have kATP channel mutations (typically diazoxide non-responsive); 19% on 2+ medical therapies, 40% on enteral feeding.
29% experienced severe hypoglycemia with loss of consciousness requiring emergency intervention in past year.
Topline safety and efficacy results from pivotal 24-week treatment period anticipated by end of 2025.

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