Rezolute showcased additional ersodetug data at ENDO 2026, highlighting congenital hyperinsulinism burden and expanded access outcomes after the Phase 3 sunRIZE study missed its primary endpoint
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
Rezolute presented four analyses at ENDO 2026 that further characterize the burden of congenital hyperinsulinism (HI) and provide additional evidence supporting ersodetug, the company’s investigational monoclonal antibody for refractory hypoglycemia associated with congenital and acquired forms of HI.
The presentations included disease-burden analyses, outcomes from an expanded access program (EAP) in tumor-associated HI, and additional interpretation of previously reported Phase 3 sunRIZE data in congenital HI.
The update follows the Phase 3 sunRIZE study (NCT06208215), which did not meet its primary endpoint of reducing hypoglycemic events compared with placebo. However, investigators reported improvements across several secondary and exploratory measures, prompting continued analysis of the dataset. The ENDO presentations provide further context regarding both the clinical burden of HI and the potential role of ersodetug across multiple patient populations.
Targeting Hyperinsulinism at the Receptor Level
Hyperinsulinism is a rare disorder characterized by excessive insulin activity that causes recurrent and potentially life-threatening hypoglycemia. Persistent low blood glucose can lead to seizures, developmental delays, cognitive impairment, and irreversible neurological injury, particularly in infants and children.
Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor, reducing excessive receptor activation by insulin and insulin-like growth factor-2 (IGF-2). By acting directly at the receptor level, the therapy has the potential to address refractory hypoglycemia across a broad range of congenital and acquired HI disorders, including insulinoma, non-islet cell tumor hypoglycemia (NICTH), and surgery-related hyperinsulinism.
New Analyses Highlight Disease Burden
Two poster presentations examined the long-term impact of congenital HI. One utilized a systematic review and meta-analysis of published studies to assess disease natural history, while a second claims-based analysis quantified neurological complications and health-economic outcomes associated with congenital HI.
Together, the studies underscored the substantial lifelong burden of the disease and highlighted the need for more effective therapies capable of preventing recurrent hypoglycemia and its complications.
Expanded Access Data Show Clinical Benefit
A separate poster reported outcomes from nine patients with refractory hypoglycemia caused by malignant insulinoma or non-islet cell tumors who received ersodetug through an expanded access program.
Among patients requiring intravenous dextrose or total parenteral nutrition (TPN) before treatment, 75% achieved complete discontinuation of IV dextrose or TPN support following therapy. The findings suggest clinically meaningful improvements in glucose control among patients with limited treatment options.
An oral presentation by Professor Huseyin Demirbilek of Hacettepe University Faculty of Medicine reviewed previously reported sunRIZE results and provided additional interpretation of the Phase 3 dataset.
Development Continues Across Late-Stage Programs
According to Chief Medical Officer Brian Roberts, M.D., deeper analyses of the sunRIZE data continue to support the therapeutic potential of ersodetug and align with observations from both the expanded access program and the ongoing Phase 3 upLIFT study (NCT06881992) in tumor-associated HI.
Rezolute continues to advance ersodetug through late-stage development in congenital and tumor-associated hyperinsulinism. Additional updates from the upLIFT study are expected as development progresses. If approved, ersodetug could provide a novel treatment option for patients with persistent, treatment-resistant hypoglycemia across multiple forms of hyperinsulinism.
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About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.