Rezolute, Inc. (RZLT) on Wednesday announced that an independent Data Monitoring Committee or DMC has issued a positive recommendation for the ongoing Phase 3 sunRIZE study of ersodetug, supporting continued enrollment without the need for a sample size increase.
The sunRIZE study is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating Ersodetug in patients with congenital hyperinsulinism, a rare pediatric condition marked by life-threatening, persistent hypoglycemia.
The interim analysis was based on predefined criteria evaluating the study's primary endpoint - hypoglycemia events — after approximately half of the participants had completed their primary assessments.
The DMC found no signs of futility and recommended that the study continue as designed.
"We are thrilled with the DMC's favorable recommendation, which we believe supports our trial design and underlying assumptions," said Brian Roberts, M.D., Chief Medical Officer of Rezolute.
He further added that, "With enrollment on track and additional U.S. sites now active, we look forward to reporting topline data later this year."
The trial is expected to enroll up to 56 patients globally, with enrollment on pace to complete in May 2025 and topline results anticipated in December 2025.
Ersodetug is a fully human monoclonal antibody that allosterically modulates the insulin receptor to reduce overactivation by insulin and IGF-2, thereby helping stabilize blood sugar levels in patients with hyperinsulinism (HI).
Unlike treatments that target pancreatic function, Ersodetug acts downstream of the pancreas, potentially offering broad effectiveness across all forms of HI.
Congenital HI is the most common cause of persistent hypoglycemia in children, often requiring intensive and long-term management. In severe cases, surgical intervention like partial or full pancreatectomy may be necessary.
Currently, RZLT is trading at $3.98, up by 27.97 percent on the Nasdaq.
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