Rezolute, Inc., a U.S. bio venture and affiliate of Handok, announced on October 11 (US time) the case of a patient with intractable hypoglycemia due to tumor-mediated hyperinsulinism (tmHI) who received RZ358 under the Expanded Access Program (EAP). The EAP is a humanitarian pathway to new medicines in pre-licensure clinical trials to expand patient access to treatment.

Rezolute previously reported the successful administration of RZ358 in a patient with intractable hypoglycemia due to metastatic insulinoma, which was published in the New England Journal of Medicine (389;8) in late August this year. A physician-researcher subsequently requested that Rezolute provide a supply of RZ358 for use in a patient with intractable hypoglycemia due to metastatic insulin-secreting cervical cancer. This was approved by the U.S. Food and Drug Administration (FDA). The patient began receiving administered RZ358 in September this year, and with a noticeable reduction of hypoglycemic symptoms, the patient was discharged from hospital and was able to resume cancer treatment. The patient continues to receive RZ358 for hypoglycemic control. Patients with metastatic insulinoma will receive administrations of RZ358 for nearly a year.

Brian Roberts, MD, Chief Medical Officer at Rezolute, said, “We are excited to bring RZ358 to patients with hyperinsulinism (HI), who are in desperate need of new treatments […] We have seen meaningful results with RZ358 in two patients with different types of tmHI. In light of these outcomes, we will continue to evaluate the effectiveness of RZ358 for different causes of HI and explore the development of additional indications.”

Rezolute’s RZ358 is a monoclonal antibody that binds to a specific site on the insulin receptor and is being developed for the treatment of congenital HI as well as other conditions characterized by excessive increase in insulin. It has received Orphan Drug Designation for the treatment of congenital HI in the U.S. and Europe and an additional Pediatric Rare Disease Designation in the U.S. In a RIZE study, a Phase 2b clinical trial of RZ358 in patients with congenital HI, Rezolute confirmed the efficacy and safety of RZ358 in treating hypoglycemia. The company plans to initiate a Phase 3 clinical trial outside the U.S. in participants 3 months of age and older in the fourth quarter of this year.

Rezolute is a bio venture that develops targeted therapies for rare, metabolic diseases. It is developing RZ358 for congenital insulinism and RZ402 for oral diabetic macular edema. Handok holds the rights to commercialize RZ358 and RZ402 in Korea.