Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism

Results Presented Today at the Pediatric Endocrine Society’s 2022 Annual Meeting

• Highly significant ~75% reduction in hypoglycemia events at anticipated therapeutic doses
• ≥50% improvement in hypoglycemia in 100% of patients in high-dose cohort, with no adverse drug reactions or clinically significant hyperglycemia
• Study exceeded expectations for correction of hypoglycemia across multiple metrics, including hypoglycemia events and time in hypoglycemia
• Predictable and dose-dependent exposures with a clear dose-response
• Good safety and tolerability across all doses with no study discontinuations or adverse drug reactions
• Results are Phase 3 enabling and demonstrate the potential for RZ358 to be used as a monotherapy as well as a potential universal therapy for all forms of hyperinsulinism
• Company hosting Analyst and Investor Conference Call, Sunday, May 1 at 2:30 p.m. ET

REDWOOD CITY, Calif., May 01, 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 results from its Phase 2b RIZE study of RZ358 in patients with congenital hyperinsulinism (HI), which were unveiled today in a late-breaking oral presentation at the Pediatric Endocrine Society 2022 Annual Meeting. The study exceeded expectations for correction of hypoglycemia, including a highly significant reduction of ~75% in hypoglycemia events by blood glucometer (BGM) as well as time in hypoglycemia by continuous glucose monitoring (CGM).

“Patients with congenital hyperinsulinism often have continued hypoglycemia in spite of available therapies, as has been clearly demonstrated in the RIZE study,” said Dr. Paul Thornton, a Pediatric Endocrinologist at Cook Children’s Hospital. Dr. Thornton continued, “The magnitude of improvement in hypoglycemia in this study demonstrates the potential for RZ358 to become a much-needed therapy for treating congenital hyperinsulinism.”

The RIZE study enrolled a diverse group of congenital HI patients with an average age of 6.5 years, including 16 patients between the ages of 2 and 6 years old, and with substantial continued hypoglycemia despite being on currently available therapies. During a robust screening and baseline run-in period on stable standard of care, the average RIZE study patient was hypoglycemic for 23% of their overall monitored time on a CGM, corroborated by having an average of 16 hypoglycemia events per week by point-of-care blood glucometer. There was also a significant amount of severe hypoglycemia at baseline (defined by glucose values below 50 mg/dL). RZ358 was administered via a thirty-minute intravenous infusion every other week for an 8-week treatment period in four sequential cohorts ranging from 3 to 9 mg/kg.

RZ358 led to a better than 50% reduction from baseline in overall (