Rezolute Reports Progress in Phase 3 Study for Rare Hypoglycemia Treatment
Rezolute reported Q4 and full fiscal year 2026 results, highlighting ongoing Phase 3 upLIFT study for tumor hyperinsulinism. Interim data showed 7 of 8 participants met the primary endpoint responder criterion, with six achieving complete discontinuation of intravenous glucose. The company also presented case series data at ENDO showing 75% of patients discontinued IV dextrose/TPN.
The upLIFT trial is a single-arm, open-label Phase 3 study enrolling up to 16 hospitalized participants with tumor HI. Enrollment remains ongoing, with topline results anticipated before year-end 2026. The company also presented a nine-patient case series at ENDO, published in JCEM, showing 75% of patients receiving IV dextrose or total parenteral nutrition achieved complete discontinuation of those therapies.
Separately, the Phase 3 sunRIZE study in congenital HI failed to meet its primary endpoint and remains under FDA review. Rezolute has supplied the agency with source datasets and extensive pre-specified, post-hoc, and sensitivity analyses focused on continuous glucose monitoring data.
This progress could offer meaningful relief for patients with tumor HI, a rare condition that often requires prolonged hospitalization and continuous intravenous glucose support. If ersodetug proves effective in the pivotal trial, it may reduce hospital dependence and improve quality of life for a small but severely affected population. However, the congenital HI setback and the single non-responder death highlight the challenges of rare disease drug development, where small sample sizes complicate efficacy assessment. Regulatory decisions will ultimately determine whether this therapy reaches patients.