Antibody Designed to Address All Forms of Hyperinsulinism (HI)
RZ358 (ersodetug) is a fully human monoclonal antibody that works downstream from the pancreas and other sources of insulin or related paraneoplastic substances and binds to an allosteric site on insulin receptors at target tissues such as liver, fat and muscle. RZ358 has the potential to be universally effective at treating hypoglycemia related to HI, whether genetic or caused by tumors.
RZ358 has been granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of cHI. RZ358 also received orphan drug and pediatric rare disease designation in the U.S., and orphan drug designation in the European Union for the treatment of insulinoma, the primary cause of islet cell tumor hypoglycemia (ICTH). Under the Company’s Expanded Access Program, multiple individuals with ICTH have been successfully treated with RZ358 resulting in substantial hypoglycemia improvement, discontinuation of intravenous dextrose, and hospital discharge.