Rezolute Reports Strong Interim Phase 3 Data for Ersodetug in Tumor Hyperinsulinism

summarizeSummary

Rezolute reported positive interim data from its Phase 3 upLIFT study for ersodetug in tumor hyperinsulinism, with 6 of 8 participants meeting the primary endpoint and discontinuing IV glucose.

check_boxKey Events · Product Development and Regulatory · RZLT

• Positive Interim Phase 3 Results

  The upLIFT study for ersodetug in tumor hyperinsulinism showed 6 of 8 participants met the primary endpoint, achieving at least a 50% reduction in intravenous glucose requirements, with all 6 completely discontinuing IV glucose.

• Study Enrollment Update

  The Phase 3 upLIFT study is now 50% enrolled, with 8 of the planned 16 participants recruited.

• Favorable Safety Profile

  Ersodetug has been well-tolerated in both the pivotal and extension phases of the study, with no drug-related adverse events reported to date.

• Future Milestones

  Topline results for the fully enrolled open-label study are expected in the second half of 2026. The company will also continue engagement with the FDA regarding the congenital HI indication.

auto_awesomeAnalysis · RZLT · Life Sciences

Rezolute announced highly positive interim results from its Phase 3 upLIFT study for ersodetug in tumor hyperinsulinism. Six out of eight enrolled participants met the primary endpoint, achieving at least a 50% reduction in intravenous glucose requirements, with all six completely discontinuing IV glucose. This strong efficacy data for an ultra-rare disease, coupled with a favorable safety profile, significantly de-risks the program and provides a clear path forward for this indication. The company also highlighted how these results validate ersodetug's mechanism, contrasting with previous challenges in the sunRIZE study for congenital HI.