Eledon Pharmaceuticals has filed a US regulatory application for a company-led study of tegoprubart in type 1 diabetes patients undergoing islet cell transplants, as it pushes forward multiple transplant programmes and a broad kidney trial scheduled for late 2026.
Eledon Pharmaceuticals has told investors that it has filed a US regulatory application to begin a company-led study of tegoprubart in people with type 1 diabetes undergoing pancreatic islet cell transplantation, while also pointing to a series of new transplant programmes and a broader kidney trial it says remains on course for late 2026. The announcement comes as the biotechnology group continues to position the experimental anti-CD40L antibody as a potential alternative to standard immunosuppression, particularly in patients vulnerable to kidney toxicity.
According to the company, the newly filed Investigational New Drug application covers a planned registrational study in islet cell transplantation, which would be its first company-sponsored trial in that setting. Eledon also said the first patients have joined an investigator-led study at the University of Chicago Medicine Transplant Institute that is assessing a calcineurin inhibitor-free regimen built around tegoprubart in patients with type 1 diabetes and chronic kidney disease receiving islet transplants.
The firm said it has also seen the first use of tegoprubart under compassionate access in two higher-risk groups: an islet transplant recipient switching away from tacrolimus because of kidney dysfunction, and a highly sensitised kidney transplant patient at Duke University Medical Centre. In addition, Eledon said a third patient has been treated in an investigator-led kidney transplant tolerance study at Massachusetts General Hospital. The company has previously reported encouraging early islet transplant results from University of Chicago, where it said all 12 treated patients became insulin-independent and showed stable graft function during follow-up.
Eledon separately reiterated that its global Phase 3 kidney transplant trial, called LEGACY, is still expected to start in the fourth quarter of 2026. The study is planned to enrol about 600 patients and will compare tegoprubart with tacrolimus, the current standard medicine used to prevent rejection after kidney transplantation. The company’s update was framed in forward-looking terms, and the ultimate value of the programme will depend on later-stage data, regulatory review and the availability of funding.
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