Significantly improved children's hereditary hypoglycemia, innovative monoclonal antibody reached the primary efficacy endpoint of Phase 2b clinical trial

On March 23, 2022, Rezolute announced that its investigational therapy RZ358 has achieved positive results in a Phase 2b clinical trial

RZ358 is a humanized monoclonal antibody that binds to a unique stereogenic site on insulin receptors in liver, fat and muscle

Image source: Reference [2]

In this multicenter, open-label, repeat-dose Phase 2b clinical trial, 23 patients with congenital HI who failed to adequately control hypoglycemia with standard therapy received RZ358 to evaluate the safety and tolerability of the drug , pharmacokinetics and glycemic efficacy

Nevan Charles Elam, CEO and Founder of Rezolute, said: "We are very encouraged by the trial results and look forward to advancing the program to Phase 3 to develop an innovative treatment option for this debilitating disease

Disease introduction:

Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children

The two most commonly used long-term drugs, diazoxide and somatostatin analogs, are not yet FDA-approved for all forms of the disease and can be associated with intolerable side effects

References:

[1] Rezolute Announces Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism.

[2] Targeting rare and metabolic diseases with transformative therapies.