Eledon Pharmaceuticals (ELDN) announced preliminary results from an investigator-initiated trial conducted at the University of Chicago Medicine’s Transplant Institute and presented at the Rachmiel Levine-Arthur Riggs Diabetes Research Symposium, held November 14-17, 2025 at City of Hope in Los Angeles, California. The ongoing trial, which has been extended to include a total of 12 subjects, is evaluating tegoprubart, Eledon’s investigational anti-CD40 Ligand antibody, as the core of a tacrolimus-free immunosuppression drug regimen for the prevention of islet transplant rejection in individuals with type 1 diabetes. The results provide updated preliminary data on the first six subjects in the trial, demonstrating the ability of tegoprubart to prevent the rejection of transplanted islet cells in the absence of calcineurin inhibition resulting in sustained insulin-free management of hemoglobin A1C in patients with T1D. All six transplanted subjects demonstrated marked improvements in glycemic control, achieving and maintaining insulin independence after one or two islet transplants, primarily depending on the subjects’ body mass and baseline daily insulin requirements. The first three participants were transplanted over a year ago and have remained insulin-free, including a patient who has maintained stable blood glucose control reflected by an HbA1c as low as 4.7%, for over 15 months without the use of exogenous insulin. Two subsequent subjects transplanted in July achieved insulin independence within approximately four weeks following a single islet transplantation and have maintained an HbA1c below 6% for over three months. A sixth subject, who was transplanted in early August, recently underwent a second islet infusion and is now insulin free with an HbA1c of 5.3%. All six patients have been free of severe hypoglycemic episodes since their transplants. Tegoprubart was generally well tolerated, with no reported serious infections, no thromboembolic or rejection events, and no signs of the kidney or neurological toxicity often observed with traditional calcineurin inhibitor-based immunosuppression.
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