RZ358

REZ-SGFX-358

Congenital hyperinsulinism (HI) is a rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas. If left untreated, elevated insulin levels can cause extreme hypoglycemic (low blood sugar) events, increasing the risk of neurologic and developmental complications, including persistent feeding problems, learning disabilities, recurrent seizures, brain damage or even death.

RZ358 is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor throughout the body, such as in the liver, fat, and muscle. The antibody modifies insulin’s binding and signaling to maintain glucose levels in a normal range which counteracts the effects of elevated insulin in the body. Rezolute believes that RZ358 is ideally suited as a potential therapy for conditions characterized by excessive insulin levels and is developing it to treat the hyperinsulinism and low blood sugar characteristic of diseases such as congenital hyperinsulinism (HI). As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating HI caused by any of the underlying genetic defects.

Publications

Continuous Glucose Monitoring (CGM) Reveals Undertreated Hypoglycemia in Patients with Congenital Hyperinsulinism

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Single Dose Studies of RZ358 in Patients with Congenital Hyperinsulinism: Results of Population PK/PD Modeling and Simulation in Adult and Pediatric Patients

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Clinical Studies

Rezolute recently revealed results from the Phase 2b study. View Results

Rezolute is planning to initiate a Phase 3 study in 2023

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