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Rezolute Announces Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism
The RIZE study demonstrated highly significant improvements in hypoglycemia and good safety and tolerability Results to be presented in an oral presentation
About this update from Rezolute, Inc.
[{"type":"text","content":"The RIZE study demonstrated highly significant improvements in hypoglycemia and good safety and tolerability Results to be presented in an oral presentation at a medical congress in 2Q 2022 REDWOOD CITY, Calif., March 23, 2022 (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 announced positive data from its Phase 2b RIZE study of RZ358. The data demonstrated the safety and tolerability of RZ358 in patients with congenital hyperinsulinism, as well as highly significant improvements in hypoglycemia. The RIZE study results will be presented in an oral presentation at an upcoming medical congress in 2Q 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,” said Nevan Charles Elam, CEO and Founder of Rezolute. Mr. Elam continued, “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.” About Congenital Hyperinsulinism (HI) 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. 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. The two most-commonly used long-term medications, diazoxide and somatostatin analogs, are not Food and Drug Administration (FDA) approved for all forms of this condition and often are ineffective or have intolerable side effects. In cases of congenital HI that are unresponsive to medical management, surgical removal of the pancreas may be requir...