Rezolute Unveils Breakthrough Ersodetug for Hypoglycemia Patients
Rezolute unveils breakthrough ersodetug (RZ358) for patients with hypoglycemia caused by congenital hyperinsulinism (HI), a rare and life-threatening condition.
Ersodetug, a fully human monoclonal antibody, works by targeting the insulin receptor to normalize insulin signaling, providing a novel treatment approach for hyperinsulinism.
The therapy is being investigated in the Phase 3 sunRIZE study, aiming to evaluate its efficacy in treating congenital HI in patients aged three months and older.
Clinical results from the Phase 2b RIZE study demonstrated a significant improvement in hypoglycemia symptoms in 75% of participants, with no major side effects.
Current treatments for congenital HI include frequent feedings, medications, or in severe cases, partial removal of the pancreas. However, these approaches are often associated with suboptimal outcomes and long-term complications, including neurodevelopmental disorders.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ersodetug for its potential to address this critical unmet need.
Rezolute is also advancing studies to explore ersodetug's use in treating tumor-related hypoglycemia, further broadening its therapeutic scope.
