Rezolute, Inc. (RZLT) Discusses Phase 3 sunRIZE Study Results and Challenges in Congenital Hyperinsulinism Transcript

Core Insights - The Phase III sunRIZE study for ersodetug in patients with congenital hyperinsulinism (HI) did not achieve statistical significance for its primary and secondary endpoints, which has caused disappointment within the company [3] - The company acknowledges the significant unmet need for new therapies in the congenital HI patient population and expresses gratitude for the participation of patients, families, and investigators in the study [2] Study Results - The study aimed to demonstrate the efficacy of ersodetug compared to placebo in an outpatient setting, where glucose levels were both the primary endpoint and a vital sign [3] - Despite the belief in the drug's potential activity, the results did not show a significant difference from the placebo group [3]