Handok announced on the 8th that its U.S. subsidiary, Resolute, has received designation as an innovative treatment for a hypoglycemia drug caused by congenital hyperinsulinemia from the U.S. Food and Drug Administration (FDA).
The FDA's designation of innovative treatment is a system that shortens the development period for drugs when the treatment effect for life-threatening diseases is significantly superior to existing therapies in the early stages of clinical trials.
The drug designated as an innovative treatment this time is 'RZ358 (active ingredient: Ercisodetug),' which is under development by Resolute. RZ358 is a monoclonal antibody that acts on specific sites of the insulin receptor, and its therapeutic effects for various diseases characterized by excessive insulin increase and hypoglycemia, such as congenital hyperinsulinemia and tumor-mediated hypoglycemia, have been confirmed.
The FDA evaluated the results of a phase 2b clinical study of RZ358 conducted on patients with congenital hyperinsulinemia. The phase 2b results showed that hypoglycemia was safely improved in over 75%, with no clinically significant hyperglycemia observed.
Nevan Charles Elam, the chief executive officer (CEO) and founder of Resolute, noted that "this designation as an innovative treatment acknowledges the potential for Ercisodetug to provide therapeutic benefits to patients with hyperinsulinemia," and added, "we plan to announce the major results of phase 3 clinical trials for patients with congenital hyperinsulinemia this year."