Rezolute Reports Positive Interim Data In Phase 3 UpLIFT Study For Ersodetug For Tumor HI

(RTTNews) - Rezolute Inc. (RZLT), a late-stage company focused on ultra-rare diseases, announced positive interim results from its ongoing Phase 3 upLIFT study of Ersodetug in patients with tumor-related hyperinsulinism (HI).

Tumor hyperinsulinism is a rare condition caused by insulinomas or non-islet cell tumors that trigger severe hypoglycemia. Current treatment options are limited, leaving patients with high unmet medical need.

The upLIFT trial has enrolled 8 of the planned 16 participants to date. Six of the first eight patients met the primary endpoint, achieving at least a 50% reduction in intravenous glucose requirements during the pivotal 8-week treatment phase. Each of these responders was also able to discontinue IV glucose entirely while on Ersodetug. One patient withdrew consent due to advanced cancer progression and was counted as a non-responder, while the eighth participant is still in dosing.

All patients completing the pivotal phase have elected to continue into the open-label extension, with cumulative treatment durations of up to six months. Ersodetug has been well-tolerated, with no drug-related adverse events reported.

CMO Dr. Brian Roberts noted that the interim findings mirror results seen in earlier compassionate use cases, underscoring the drug's hypoglycemia-correcting activity across different tumor types. Rezolute expects topline results from the fully enrolled study in the second half of 2026.

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor reducing over-activation by insulin and IGF-2. The therapy is being developed as a potential universal treatment for refractory hypoglycemia caused by congenital or acquired forms of hyperinsulinism, including tumor HI and post-surgical cases.

RZLT has traded between $1.07 and $11.45 over the past year. The stock is currently trading at $3.96, up 9.42%.