Rezolute Receives Breakthrough Therapy Designation for Ersodetug (RZ358) in Hypoglycemia Treatment
Rezolute announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ersodetug (RZ358) for addressing hypoglycaemia caused by congenital hyperinsulinism (HI).
The Breakthrough Therapy Designation aims to accelerate the development and regulatory review of treatments for serious or life-threatening conditions.
This designation reflects promising clinical evidence showing substantial improvements in outcomes compared to existing therapies. In this case, it is based on the results of the Phase 2b (RIZE) study, which demonstrated significant improvements in hypoglycaemia, with a reduction of 75% or more, without notable cases of hyperglycaemia.
Congenital HI is a primary cause of recurrent hypoglycaemia in children, often presenting within the first month of life. Untreated, it can lead to severe complications, including brain damage, seizures, and developmental issues.
For cases unresponsive to medical treatments, surgical removal of the pancreas may be required. Many children require long-term management due to the lack of effective therapies.
Ersodetug is a fully human monoclonal antibody designed to bind allosterically to the insulin receptor. By moderating the over-activation caused by insulin and related substances, the treatment helps normalise insulin signalling and improve hypoglycaemia.
As it works downstream from the pancreas, ersodetug has the potential to be effective for both congenital and acquired forms of HI.
