Ersodetug
Our antibody is designed to address all forms of hyperinsulinism.
In congenital HI, existing treatment options are frequently associated with serious side effects, poor tolerability, or inadequate glucose control. Many patients don’t respond to the standard of care, putting them at risk of neurological damage or even death.
In tumor HI – including insulinoma and non-islet cell tumors (NICTs) – the resulting hypoglycemia can be severe, sometimes requiring hospitalization and preventing adjuvant tumor treatment. Unfortunately, treatment options remain limited, with many proving ineffective or difficult for patients to tolerate.
Across both forms of HI, patients who can’t manage their condition with current therapies are in urgent need of innovative, effective treatments – that’s where Rezolute comes in.
Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any form of of HI.
Currently, ersodetug is being evaluated in two Phase 3 registrational trials for congenital and tumor HI. It has demonstrated meaningful benefit in both clinical studies and real-world use. In the Phase 2 RIZE study, nearly all participants with congenital HI achieved significant improvement in hypoglycemia across multiple endpoints. At the doses and exposures being used in the ongoing sunRIZE study, ersodetug was generally safe and well-tolerated, and it resulted in median improvements in hypoglycemia of up to ~90% at top doses.
Beyond clinical trials, under the Company’s Expanded Access Program, multiple patients with tumor HI have been successfully treated with ersodetug. These patients experienced meaningful hypoglycemia improvement, discontinuation of intravenous dextrose, hospital discharge, and resumption of tumor-directed therapies.
Ersodetug has received multiple regulatory designations recognizing its potential to address serious unmet needs. These include priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the UK Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of congenital HI. In the US, ersodetug has received both orphan drug and pediatric rare disease designations, and in the European Union, orphan drug designation for the treatment of insulinoma, the primary cause of islet cell tumor hypoglycemia (ICTH).