Eledon Pharmaceuticals has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for a registrational clinical trial evaluating tegoprubart in type 1 diabetes patients undergoing pancreatic islet cell transplantation.
The planned study would mark the company’s first internally sponsored trial in islet cell transplantation, a procedure aimed at restoring insulin production in patients with type 1 diabetes. Tegoprubart, an anti-CD40L antibody, is being developed as an immunosuppression therapy for transplant patients to prevent organ rejection.
In parallel, investigator-initiated trials at academic medical centers are advancing. The University of Chicago Medicine Transplant Institute has enrolled patients in a study assessing tegoprubart in type 1 diabetes patients with chronic kidney disease-related renal dysfunction receiving islet cell transplants without calcineurin inhibitors. The center has expanded enrollment to include three additional patients, bringing the total treated to 15. Earlier data from the first 12 patients showed all achieved insulin independence and hemoglobin A1c levels below 7.0%, with stable islet graft function over a maximum follow-up of 22 months.
Compassionate-use protocols have also been initiated. The first islet cell transplant recipient received tegoprubart to transition from tacrolimus-based immunosuppression due to calcineurin inhibitor-related renal dysfunction. Separately, Duke University Medical Center dosed the first highly sensitized kidney transplant patient under a compassionate-use protocol.
At Massachusetts General Hospital, a third patient has been treated in an investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction. Eledon remains on track to initiate its global Phase 3 LEGACY trial in kidney transplantation in the fourth quarter of 2026, with plans to enroll approximately 600 patients.
