Rezolute Reports Positive Early Results in Rare Disease Study for Tumor Hyperinsulinism
Rezolute Highlights Strong Early Response Trends In Rare Hypoglycemia Disease Study
Image: Benzinga
Rezolute, Inc. has announced interim results from its Phase 3 upLIFT study, revealing that six out of eight participants with tumor hyperinsulinism met the primary endpoint, showing significant reductions in intravenous glucose needs. The study aims to enroll 16 patients and has been well-tolerated so far.
- 01Six out of eight participants achieved at least a 50% reduction in intravenous glucose requirements during the eight-week treatment phase.
- 02All six responders were able to completely discontinue intravenous glucose therapy while on ersodetug.
- 03One participant withdrew from the study due to transitioning to hospice care and was classified as a non-responder.
- 04The trial has enrolled eight participants so far, halfway to its target of 16.
- 05No drug-related adverse events have been reported, indicating a favorable safety profile for ersodetug.
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Rezolute, Inc. (NASDAQ:RZLT) has provided an interim update on its Phase 3 upLIFT study, which evaluates the efficacy of ersodetug in treating tumor hyperinsulinism (HI), a rare condition linked to hypoglycemia caused by certain tumors. Out of eight participants enrolled, six have met the primary endpoint by achieving at least a 50% reduction in intravenous glucose requirements during the eight-week treatment period. These six individuals were also able to completely discontinue intravenous glucose therapy. The trial is currently halfway to its enrollment goal of 16 patients. Notably, one participant withdrew from the study due to a transition to hospice care and was classified as a non-responder. All participants who completed the treatment phase opted to continue into an open-label extension phase, with no reported adverse events related to the drug, suggesting a favorable safety profile. Following this news, Rezolute shares rose by 15.65% to $4.18.
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The successful results from the upLIFT study could lead to improved treatment options for patients with tumor hyperinsulinism, potentially affecting their quality of life and treatment protocols.
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