Rezolute Inc. announced insights from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism $(HI)$ and shared findings from its Expanded Access Program (EAP) in tumor-induced HI. According to the company, data from both the sunRIZE study and the EAP demonstrate evidence of activity of ersodetug in these indications. In the EAP, 75% of patients previously dependent on intravenous dextrose or total parenteral nutrition were able to completely discontinue these treatments. Additionally, more than a dozen patients with severe and refractory hypoglycemia due to tumor HI reportedly experienced substantial improvements, including reduced glucose infusion rates or complete discontinuation of infusion. The results from these studies have already been presented and discussed with the U.S. Food and Drug Administration. Rezolute plans to continue discussions with the FDA regarding the path forward for congenital HI.
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