Rezolute receives FDA IND clearance for Phase 3 study of RZ358 in tumor hyperinsulinism

Rezolute, Inc.

FDA cleared IND for RZ358 (ersodetug) Phase 3 registrational trial treating hypoglycemia due to tumor HI.
Double-blind, placebo-controlled study of 24 participants; enrollment expected to start H1 2025.
Ongoing Phase 3 for congenital HI; topline data anticipated mid-2025.
Drug is a fully human monoclonal antibody binding to insulin receptor allosteric site.
Prior Expanded Access Program showed real-world benefit in tumor HI patients.

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