Rezolute to Initiate a Pivotal Phase 3 Study of RZ358 in Participants 3 Months of Age and Older with Congenital Hyperinsulinism

Study to be initiated in Europe and other ex-US geographies in Q4 2023, with topline results expected 1H 2025

Conference call scheduled today at 4:30 p.m. ET 

REDWOOD CITY, Calif., June 27, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today provided an update on its clinical development plans for RZ358, the Company’s product candidate for congenital hyperinsulinism (congenital HI). Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023, with topline results anticipated in the first half of 2025. The sunRIZE study is a randomized, double-blind, placebo-controlled, parallel arm evaluation of RZ358 in participants with congenital HI who are not adequately responding to standard of care medical therapies. The Phase 3 study follows the Company’s successful Phase 2b RIZE study which demonstrated that RZ358 was generally safe and well-tolerated, as well as effective in improving hypoglycemia in participants who were failing available medical therapies.

The Company has concluded its pre-Phase 3 regulatory and scientific advice meetings with European health authorities and has reached agreement on the sunRIZE study design, that will include participants 3 months of age and older. In the US, the Company has had similar interactions with the US Food and Drug Administration (FDA) culminating in a meeting held with the agency on May 24, 2023, and FDA has maintained an existing age restriction of 12 years and older on RZ358 clinical studies and implemented dose level restrictions for RZ358 based on historical rat toxicology findings. The FDA restrictions make it infeasible to include the US in the sunRIZE study at this time, particularly given that the pediatric population with congenital HI has the greatest therapeutic need. The Company is evaluating potential nonclinical studies to address FDA’s concerns in parallel with the initiation and advancement of sunRIZE outside of the US.