Rezolute Reports Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism
Mar 23, 2022 By MarketDepth
Rezolute, Inc. (NASDAQ: RZLT) reported positive data from its Phase 2b RIZE study of RZ358. Data has demonstrated the safety and tolerability of RZ358 in patients with congenital hyperinsulinism, including significant improvements in hypoglycemia. The results will be presented in an oral presentation at an upcoming medical congress in the second quarter of 2022, followed by a conference call hosted by the Company to discuss the data.
“We are very encouraged by the results and are looking forward to moving the program into Phase 3, We are very grateful to the patients, their families, patient advocacy organizations, and the investigators who participated in this study. I also appreciate the tremendous dedication of the Rezolute team, who are mission driven to develop an innovative treatment option for this debilitating condition.”Nevan Charles Elam, CEO and Founder of Rezolute
Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children. It typically presents early in life, with about 60% of infants with congenital HI experiencing hypoglycemia within the first month of life. RIZE is a Phase 2b, multicenter, open label, repeat-dose study, designed to assess the safety and tolerability, pharmacokinetics, and glycemic efficacy of RZ358 administered bi-monthly for 8 weeks in patients with congenital hyperinsulinism whose hypoglycemia was not adequately controlled on standard of care therapies. A total of 23 patients participated in the study in four sequential dosing cohorts ranging from 3 mg/kg to 9 mg/kg. The effects of RZ358 on hypoglycemia were assessed by continuous glucose monitor (hypoglycemia time) and glucometer self-monitored blood glucose (hypoglycemia events).