Ersodetug (RZ358) - (upLIFT)

June 2, 2026: Rezolute, Inc. (NASDAQ: RZLT) provided an interim update from its ongoing open-label Phase 3 upLIFT registrational study of ersodetug in tumor hyperinsulinism (HI), including insulinoma and non-islet cell tumor hypoglycemia. Enrollment is 8 of 16 planned participants (~50%). The primary endpoint is the proportion of participants achieving ≥50% reduction from baseline in IV glucose requirements (glucose infusion rate; GIR) within the 8-week pivotal treatment phase.

Of 8 enrolled, 6 have already met the responder criterion, and each of these 6 discontinued IV glucose with ersodetug. One participant withdrew consent before completing the pivotal phase during hospice transition for stage 4 metastatic colon cancer and is counted as a non-responder. The 8th participant is still dosing in the pivotal phase. All participants who completed the 8-week period elected to continue into the open-label extension (up to 6 months cumulative treatment).

Ersodetug was reported as well-tolerated with no drug-related adverse events or other safety findings to date. Topline results for the fully enrolled upLIFT study are expected in the second half of 2026. Rezolute also said it is continuing engagement with FDA on the path forward for congenital HI.