Irvine, California — November 19, 2025 — Leads & Copy — Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) has announced promising preliminary results from an investigator-initiated trial of its investigational drug, tegoprubart, for preventing islet transplant rejection in individuals with type 1 diabetes. The trial, conducted at the University of Chicago Medicine’s Transplant Institute, was presented at the Rachmiel Levine-Arthur Riggs Diabetes Research Symposium.
The ongoing trial, which has been expanded to include 12 subjects, is evaluating tegoprubart, Eledon’s anti-CD40 Ligand antibody, as the core of a tacrolimus-free immunosuppression drug regimen. Updated preliminary data from the first six subjects show tegoprubart’s ability to prevent rejection of transplanted islet cells without calcineurin inhibition, leading to sustained insulin-free management of hemoglobin A1C (HbA1c) in patients with type 1 diabetes (T1D).
All six transplanted subjects experienced significant improvements in glycemic control, achieving and maintaining insulin independence after one or two islet transplants. The need for one or two transplants was primarily based on the subjects’ body mass and baseline daily insulin requirements. The first three participants, transplanted over a year ago, have remained insulin-free, with one patient maintaining stable blood glucose control (HbA1c as low as 4.7%) for over 15 months without exogenous insulin.
Two subsequent subjects, transplanted in July 2025, achieved insulin independence within approximately four weeks of a single islet transplantation, maintaining HbA1c below 6% for over three months. The sixth subject, transplanted in early August 2025, recently became insulin-free after a second islet infusion, with an HbA1c of 5.3%. Since their transplants, all six patients have been free of severe hypoglycemic episodes.
According to Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, these data suggest that tegoprubart may transform islet transplantation. The current standard of care is calcineurin inhibitors including tacrolimus, which are often associated with debilitating metabolic, neurologic, and cardiovascular toxicities. The six subjects in the UChicago Medicine clinical trial achieved insulin independence, suggesting that tegoprubart may be the innovative immunosuppression therapy needed to transform islet transplantation.
Tegoprubart was generally well tolerated. No serious infections, thromboembolic or rejection events, or signs of kidney or neurological toxicity (often observed with calcineurin inhibitors) were reported.
Esther Latres, Ph.D., Breakthrough T1D Senior Vice President, Research, stated that Breakthrough T1D is encouraged by the data from the investigational use of tegoprubart as a novel immunosuppression alternative to advance islet transplantation and looks forward to continuing to support this promising research.
The clinical trial is funded by Breakthrough T1D (formerly JDRF), with initial support from The Cure Alliance. Breakthrough T1D has also committed to funding a second study evaluating tegoprubart to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.
Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. The islet cells lodge in small blood vessels in the liver and release insulin. Post-procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.
Eledon Pharmaceuticals, Inc. is a clinical-stage biotechnology company developing immune-modulating therapies for life-threatening conditions. Its lead investigational product, tegoprubart, is an anti-CD40L antibody with high affinity for the CD40 Ligand. The company is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California.
Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com
Source: Eledon Pharmaceuticals, Inc.
