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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.
