Rezolute, Inc.

Rezolute, Inc. is a late-stage rare disease company focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). The company's lead clinical asset is ersodetug, a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism. Ersodetug is an intravenously administered human monoclonal antibody that binds to a unique site on the insulin receptor in insulin target tissues like the liver, fat, and muscle. This antibody down modulates insulin's binding, signaling, and action, counteracting the effects of elevated insulin and helping to restore glucose to a more normalized range. Ersodetug exhibits dose-dependent pharmacokinetics with a half-life greater than 2 weeks, suggesting potential for monthly dosing. The company is developing ersodetug to treat hyperinsulinism, believing it is suitable for conditions characterized by excessive insulin or insulin-like levels. As ersodetug acts downstream from beta cells, it has the potential to be universally effective at treating hypoglycemia related to HI, whether genetic or acquired. For congenital hyperinsulinism, an ultra-rare pediatric genetic disorder, Rezolute completed enrollment in May 2025 for the pivotal Phase 3 clinical study, "sunRIZE," for ersodetug. The study aimed to enroll approximately 56 participants in more than a dozen countries, including U.S. patients, and exceeded its enrollment target. The sunRIZE study is a global, randomized, double-blind, placebo-controlled, parallel arm evaluation of ersodetug in participants 3 months of age and older with congenital HI who are not adequately responding to standard medical therapies.