Rezolute, Inc. (RZLT) Wednesday reported that its Phase 3 sunRIZE study in failed to meet its primary endpoint of reducing hypoglycemia events or the key secondary endpoint of time spent in hypoglycemia. However, in line with its Phase 2 RIZE study results, the drug candidate showed pharmacologic activity. The study was designed to evaluate the safety and efficacy of Ersodetug in patients with congenital hyperinsulinism.
Furthermore, 57 out of 59 chose to enter the Open-Label Extension, with some children reportedly able to stop all other therapies and maintain stability on ersodetug monotherapy.
The antibody therapy, Ersodetug expressed biomarker responses and was consistent with reduced insulin activity.
Congenital hyperinsulinism or HI is a rare condition that causes persistent low blood sugar in infants and children, often requiring intensive monitoring and treatment. Rezolute noted that despite the placebo effect observed in the trial, reductions from baseline in hypoglycemia events were seen in both treatment groups.
In tumor HI, which can occur in patients with insulinomas or other neuroendocrine tumors, Rezolute's expanded access program has treated more than a dozen patients across the U.S. and Europe. Data showed that 75% of participants dependent on IV dextrose or parenteral nutrition were able to discontinue these therapies after receiving Ersodetug.
These results support the ongoing Phase 3 upLIFT study, which is designed to measure reductions in glucose infusion rates in a controlled hospital setting, with topline data expected in the second half of 2026.
Rezolute plans to meet with the FDA under its Breakthrough Therapy Designation to discuss the path forward for congenital HI, while continuing to advance Ersodetug as a potential therapy for both hyperinsulinism.
RZLT has traded between $1.07 and $11.45 over the past year. The stock is currently trading at $2.24, up 17.53%.
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