Rezolute Announces Initiation of Dosing in the Second Cohort of its Phase 2b Trial of RZ358 for Congenital Hyperinsulinism
Tracking to Announce Top line data in Q1 2022
REDWOOD CITY, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced that it has begun dosing patients in the second cohort of its Phase 2b clinical trial of RZ358 (RIZE). RZ358 is a monoclonal antibody targeting the treatment of hypoglycemia caused by excessive insulin levels and is currently in clinical development for congenital hyperinsulinism (HI), a rare pediatric endocrine disorder.
Rezolute reported that a dose escalation review committee, comprised of HI expert investigators, voted to approve dose escalation and initiation of cohort 2 (6 mg/kg), based on their interim review of safety data from Cohort 1 (3 mg/kg). Following completion of the second cohort, the company plans to initiate a third and likely final cohort at 9 mg/kg.
“We are making great strides with the RIZE study and based on our recent clinical trial activity, we are tracking toward the original timeline we laid out prior to the COVID-19 pandemic. In that regard, we are expecting to substantially complete enrollment by the end of 2021 and have top-line data in Q1 of 2022,” said Brian Roberts, MD, Senior Vice President and Head of Clinical Development at Rezolute. “We will continue to monitor the evolution of the pandemic, including the impact of the Delta variant, which could alter our ability to screen and enroll patients in a timely fashion.”
Rezolute also announced the addition of Adrian Vella, MD, Professor of Medicine in the Endocrinology Division at the Mayo Clinic College of Medicine, to the Company’s Scientific Advisory Board. Dr. Vella is a leading expert in hypoglycemic disorders and will provide guidance on the development of RZ358.
Dr. Roberts noted, “We are pleased to welcome Dr. Vella to our Scientific Advisory Board. Given his background and knowledge of RZ358, he will be extremely valuable to Rezolute as we advance the development of RZ358 for HI and evaluate the possibility of expanding into other related and applicable indications.”
Dr. Vella is a Professo of Medicine in the Mayo Clinic College of Medicine and has published over 160 peer reviewed articles related to endocrinology, metabolic disorders, and diabetes. He is regularly the lead author or editor on evidence-based reviews of hyperinsulinism and hypoglycemia.
About RIZE (RZ358-606)
RZ358 received Orphan Drug Designation in the United States and European Union as well as Pediatric Rare Disease Designation in the US. Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with congenital hyperinsulinism.
About Rezolute, Inc.
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