Phase 2 RIZE Study Sub-Analyses to be Presented at the 2024 Pediatric Endocrine Society Annual Meeting

REDWOOD CITY, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that a poster titled “An Analysis of Overnight Hypoglycemia in Patients with Congenital Hyperinsulinism: Results from the RZ358-606 (RIZE) Study” will be presented at the Pediatric Endocrine Society (PES) Annual Meeting, to be held May 2-5, 2024 at the Sheraton Grand Chicago Riverwalk.

Paul Thorton, M.D., of Cook Children’s Medical Center in Fort Worth, Texas, will present the poster, which details findings from the Company’s Phase 2 RIZE study evaluating the treatment of congenital hyperinsulinism (HI) with RZ358 in pediatric patients. While primary and key secondary glycemic endpoints (weekly events and daily percent time) from the RZ358-606 (RIZE) study have been previously reported, the current sub-analyses highlight the benefits of RZ358 during the vulnerable overnight fasting period, utilizing continuous glucose monitor (CGM) to evaluate average time in hypoglycemia (<70 mg/kg) and average glucose levels overnight. These and previously reported results, including improvements in overall hypoglycemia events and time of up to ~90% at the top doses, suggest that RZ358 has the potential to be a safe and effective therapy to treat all forms of congenital HI. A Phase 3 study is currently underway.

Presentation Details
Date: Saturday, May 4, 2024
Time: 12:15 p.m. local time
Abstract ID: 6790

For more information on the conference presentation schedule and to view the poster abstract, please visit the PES Annual Meeting website.

About Congenital Hyperinsulinism

Congenital hyperinsulinism (HI) is the most common cause of recurrent and persistent hypoglycemia in children. Patients with congenital HI typically present with signs or symptoms of hypoglycemia within the first month of life. These episodes can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties, and significant impact on patient and family quality of life. In cases of congenital HI that are unresponsive to medical management, surgical removal of the pancreas may be required. In those with diffuse congenital HI where the whole pancreas is affected, a near-total pancreatectomy can be undertaken, although about half of these children will continue to have hypoglycemia and require medical treatment for congenital HI.