(RTTNews) - Rezolute, Inc. (RZLT) will present new findings from its pivotal Phase 3 sunRIZE study evaluating Ersodetug, a monoclonal antibody designed to treat hypoglycemia caused by congenital hyperinsulinism (HI), at the Pediatric Endocrine Society (PES) Annual Meeting on May 1, 2026.
The oral presentation will include previously announced topline results along with additional pre-specified and post-hoc analyses that the company says continue to demonstrate target engagement and therapeutic benefit.
Study Overview
The sunRIZE Phase 3 trial is a global, multi-center, randomized, double-blind, placebo-controlled, study enrolling 63 participants aged 3 months to 45 years with congenital HI who continued to experience hypoglycemia despite standard of care (SOC) therapy. Participants were randomized to receive Ersodetug 5 mg/kg, 10 mg/kg or placebo as an add-on to existing SOC. Dosing occurred every other week during an initial loading phase and every four weeks during the six-month pivotal period.
The study evaluated:
-Primary endpoint: change from baseline in the average number of hypoglycemia events per week
-Key secondary endpoint: change in average percent time spent in hypoglycemia over six months What Will Be Presented on May 1
According to Rezolute, the PES presentation will feature:
-The topline results previously disclosed
-Pre-specified analyses that the company believes continue to demonstrate target engagement and the therapeutic benefit of Ersodetug.
The presentation will be delivered by Diva D. De León-Crutchlow, MD, MSCE, during the session on Friday, May 1, 2026. From 8:15-9:19 a.m. PT.
Mechanism and Potential Impact
Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor, reducing excessive receptor activation caused by insulin or IGF-2. Because it acts downstream of the pancreas, the therapy has the potential to be effective across all congenital and acquired forms of HI, regardless of genetic subtype.
Next Step The company stated that "Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive Ersodetug."
RZLT has traded between $1.07 and $11.45 over the past year. The stock closed Wednesday's trading at $3.12, up 1.63%. During after-hours trading the stock traded at $3.15, up 0.96%.
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