Rezolute Receives Rare Pediatric Disease Designation for RZ358, Phase 2b Candidate for the Treatment of Congenital Hyperinsulinism, Enabling Eligibility for Priority Review Voucher

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[{"type":"text","content":"REDWOOD CITY, Calif., June 10, 2020 (GLOBE NEWSWIRE) -- Rezolute, Inc. (“Rezolute” or “the Company”) (OCTQB:RZLT), today announced that the company has received rare pediatric disease designation (RPD) from the Food and Drug Administration (FDA) for RZ358, a potential treatment for congenital hyperinsulinism (HI) that is currently being evaluated in a global Phase 2b study.\n According to an FDA Guidance for Industry document (July 2019) concerning the incentive program for rare pediatric diseases, Rezolute now qualifies to be eligible for a Rare Pediatric Disease Priority Review Voucher as the sponsor of RZ358. Following an approval of RZ358 for congenital HI in pediatrics, such a voucher could be redeemed to receive a priority review of a subsequent marketing application. “If we are successful at obtaining final approval for RZ358, we may obtain a valuable and transferable priority review designation for any subsequent marketing application that Rezolute could choose to utilize in the best interest of its shareholders,” said Nevan Elam, J.D., chief executive officer of Rezolute. “As there is currently no approved therapy with a label indication specifically for congenital hyperinsulinism, patients typically rely on treatments that are not optimal for the disorder. As a result, patients often experience serious side effects or limited drug efficacy. RZ358 is designed to restore healthy levels of insulin action in congenital HI for patients of any age – including children.” RZ358 is a monoclonal antibody designed specifically to address congenital HI, an ultra-rare genetic endocrine disorder that appears in 1 in 25,000 to 1 in 50,000 live births in many populations. Congenital HI is characterized by excess insulin secretion, which causes repeated episodes of low blood sugar, or hypoglycemia. The condition often goes unnoticed in infants, putting them at risk of complications of recurring hypoglycemic events, including developmental delays, seizures, coma and death. About Rezolute, Inc. Rezolute is advancing targeted therapies for rare, metabolic, and life-threatening diseases. Its lead clinical asset, RZ358, is in Phase 2b development as a potential treatment for congenital hyperinsulinism, a rare pediatric endocrine disorder. Its pipeline also includes RZ402, an orally available plasma kallikrein inhibitor in late-stage preclin...

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