Maximum 75% Reduction in Severe Hypoglycemia Incidence in RZ358 Treatment Group
[Asia Economy Reporter Lee Gwan-joo] RZ358, a treatment for congenital hyperinsulinism developed by the U.S. company Rezolute, demonstrated significant effects such as blood glucose improvement in its Phase 2 clinical trial. Rezolute is a bio-venture company with HanDok and Genexine, domestic pharmaceutical and bio companies, as its major shareholders.
According to industry sources on the 4th, Rezolute announced the key results of the Phase 2b clinical trial (RIZE study) of RZ358 at the annual meeting of the Pediatric Endocrine Society in the U.S. on the 1st (local time).
The study involved 16 patients aged 2 to 6 years with severe persistent hypoglycemia, with an average age of 6.5 years, all diagnosed with congenital hyperinsulinism. The patients were administered three different doses, and blood glucose levels were continuously monitored using a continuous glucose monitor (CGM).
Results showed that the time blood glucose dropped to hypoglycemic levels (below 70 mg/dL) accounted for 23% of the total monitoring time, and the average number of hypoglycemic episodes decreased from 15.5 at the start of treatment to 7.5 at the end. The time spent in severe hypoglycemia was reduced by up to 75%.
Additionally, hypoglycemia improved in more than 50% of patients receiving high doses and high cohorts, with no drug side effects or clinically significant hyperglycemia observed. There were no cases of study discontinuation due to adverse drug reactions.
Dr. Paul Sutton, a pediatric endocrinologist at Cook Children’s Hospital, stated, "Patients with congenital hyperinsulinism continuously experience hypoglycemia," adding, "The improvement in hypoglycemia observed in this study suggests that RZ358 could be an important treatment option for congenital hyperinsulinism."
Meanwhile, Rezolute successfully raised a total of $130 million through direct offering and private placement, where the company directly distributed shares to institutions. Rezolute plans to use the raised funds for the Phase 3 clinical trial of RZ358 for congenital hyperinsulinism, the Phase 2 clinical trial of RZ402 for diabetic macular edema, and further pipeline expansion.
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