Rezolute Reports 75% of EAP Patients Achieved Complete Discontinuation of IV Dextrose
Over the past two years, Rezolute has collaborated with investigators across the United States and in Europe to provide ersodetug to more than a dozen patients with severe and refractory hypoglycemia due to tumor HI, including malignant pancreatic neuroendocrine tumors and non-islet cell tumors. The Company has previously reported that the therapy was generally well-tolerated, and that patients experienced substantial improvement in hypoglycemia, which led to a reduction in the rate of glucose infusion in the hospital or the complete discontinuation of infusion and discharge from the hospital. Presented in a table filed on Form 8-K with the U.S. Securities and Exchange Commission are cumulative data from the initial 9 participants in the EAP, including patient characteristics, ersodetug dosing, and observed outcomes. This same data cohort was provided to FDA last year in support of the Company's request for Breakthrough Therapy Designation and subsequently informed the discussion with FDA that led to revision of the Phase 3 upLIFT study in tumor HI to a single arm, open-label study. In summary, 75% of the patients receiving IV dextrose/total parental nutrition in the EAP achieved a complete discontinuation of IV dextrose/TPN. This outcome is highly relevant to the ongoing upLIFT study and provides additional evidence of the activity and potential efficacy of ersodetug across various forms of HI. Notably, the GIR assessment in the EAP is the primary endpoint in upLIFT, which measures the number of participants who achieve at least a 50% reduction in GIR, an objective endpoint in a highly controlled hospital setting. For statistical significance, 9 of 16 open-label participants need to achieve this threshold. Topline results are anticipated in the second half of 2026.
