Pharma Friday: Endocrine News Roundup on Rezolute's Hyperinsulinism Programs

An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism On January 7, Rezolute, Inc., a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), shared observations from the Phase 3 sunRIZE study in patients with congenital HI and provided details on the treatment of tumor HI patients with ersodetug under the Company’s EAP.

While sunRIZE did not meet its primary (hypoglycemia events) or key secondary (time in hypoglycemia) endpoints, the Company believes that the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. Specifically, there was evidence of pharmacologic activity as target therapeutic drug concentrations were achieved in both treatment groups (5 mg/kg and 10 mg/kg) with highly sensitive biomarker responses (increases in circulating insulin) in the active treatment groups that are indicative of reduced insulin activity at its receptor.