Rezolute Initiates Phase 2b Clinical Trial of Lead Candidate RZ358 in Congenital Hyperinsulinism
Rezolute, Inc, announced the initiation of the RIZE study (RZ358-606), a Phase 2b clinical trial of its lead candidate, RZ358, in patients with congenital hyperinsulinism (CHI). The Company has screened the first patient and expects to make significant enrollment progress to enable attainment of mid-study results over the coming year.
“Congenital hyperinsulinism is the most common cause of persistent low blood sugars in infants and children and often leads to serious neurologic complications,” said Brian Roberts, M.D., head of clinical development at Rezolute in a press release. “Given that existing medical or surgical therapies are often ineffective or have significant side effects or long term risks, the availability of a safe and effective treatment option could have a profound impact for patients and families living with CHI, by relieving the fear of dangerously low blood sugars. This study will provide additional insights and build on the favorable results already demonstrated in earlier clinical trials evaluating RZ358 in patients with this rare disease.”
This multi-center, open-label, repeat-dose study will assess the safety, tolerability and efficacy of RZ358 in patients who are at least two years old with CHI and who have residual hypoglycemia that is inadequately controlled on existing therapies. In addition to safety and pharmacokinetic evaluations, continuous glucose monitoring and self-monitored blood glucose will be utilized to evaluate several glycemic efficacy endpoints.
For more information on the clinical trials, click here.