REDWOOD CITY, Calif. - Rezolute , Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company, has announced promising results from a preclinical study indicating that its lead compound, RZ358, could effectively treat hypoglycemia resulting from non-islet cell tumors (NICTs) that cause hyperinsulinism. The study's findings suggest a potential to more than double the addressable patient population living with this condition.
The company's recent in vitro pharmacology research assessed RZ358's impact on insulin receptor activation by insulin-like growth factor-2 (IGF-2), compared to insulin, at disease-relevant concentrations. The results demonstrated RZ358's ability to blunt signaling from both IGF-2 and insulin, supporting the compound's broad therapeutic applicability in treating hypoglycemia from various forms of hyperinsulinism.
Dr. Brian Roberts, Chief Medical Officer at Rezolute, expressed optimism for RZ358's potential to offer significant therapeutic benefits to cancer patients with limited options for managing hypoglycemia, which can complicate cancer treatment. The company had previously reported successful use of RZ358 under its Expanded Access Program for patients with insulin-producing pancreatic islet cell tumors.
Rezolute has engaged with the U.S. Food and Drug Administration (FDA) regarding a potential single registrational study that may include patients with hypoglycemia due to both islet cell tumor hypoglycemia (ICTH) and NICTH. The inclusion of NICTH patients could significantly expand the market for RZ358 in tumor hyperinsulinism, estimated at approximately 4,500 patients in the U.S.
RZ358 is a fully human monoclonal antibody targeting an allosteric site on insulin receptors, designed to counteract excess insulin receptor activation and improve hypoglycemia. The compound is also in a Phase 3 trial for congenital hyperinsulinism, a rare pediatric condition where children overproduce insulin. RZ358 has received Orphan Drug Designation in the U.S. and EU for congenital hyperinsulinism treatment, as well as additional designations for its use in treating insulinoma.
This announcement is based on a press release statement and contains forward-looking statements regarding the potential efficacy and therapeutic applications of RZ358. These statements are not guarantees of future performance and are subject to risks and uncertainties.
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