Rezolute reports evidence of RZ358’s efficacy in tumor-mediated hyperinsulinism

Rezolute announced results following administration of RZ358 to a patient with refractory hypoglycemia due to tumor-mediated hyperinsulinism on a compassionate-use basis, under its expanded access program. The Company previously reported on the successful use of RZ358 for a patient with refractory hypoglycemia due to metastatic insulinoma, which has since been published in a recent edition of the New England Journal of Medicine. As a result of that publication, the Company recently received and granted a request from a physician-investigator who had FDA approval to use RZ358 for a patient with refractory hypoglycemia due to a metastatic, insulin-secreting cervical cancer. The patient began receiving treatment with RZ358 in September 2023, which resulted in resolution of her hypoglycemia and enabled her to be discharged from the hospital to resume cancer-directed therapy while continuing to receive RZ358 to control hypoglycemia. “Not only is it gratifying to be able to provide RZ358 to patients who desperately need new therapies for hyperinsulinism, we are extremely encouraged by the very favorable glycemic outcomes achieved in these two patients with different types of tumor-mediated HI,” remarked Brian Roberts, MD, Chief Medical Officer at Rezolute. “We believe that this provides further validation of our long-held view of hyperinsulinism as a group of related conditions, and RZ358 as a potential universal treatment for any of the various causes of hyperinsulinism, whether congenital, induced by gastric bypass, or mediated by tumors.”