– All 12 patients in study (100%) achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their T1D
– All 12 patients also achieved an HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4%, representing an approximately 2.6% average improvement in HbA1c from baseline
– No severe hypoglycemic episodes were reported post-transplant, compared with a history of recurrent severe hypoglycemic events prior to transplantation in all enrolled patients
IRVINE, Calif., June 08, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial evaluating tegoprubart, its investigational anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute. The results were presented by trial investigator Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.
All patients treated in the study (n=12) showed rapid improvement in glycemic control following islet transplantation and treatment with tegoprubart, with stable islet graft function observed across the cohort over a median and maximum post-transplant follow-up period of 8 and 22 months, respectively. All 12 patients achieved insulin independence, meaning that they no longer needed chronic, exogenous insulin therapy to manage their T1D. Also, all patients demonstrated a most recent hemoglobin A1C (“HbA1c”) below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4% across the cohort.
While all patients enrolled reported recurrent severe hypoglycemic events pre-transplant, no severe hypoglycemic episodes were reported following transplantation. Severe hypoglycemia is a serious complication of type 1 diabetes that may require emergency medical intervention and can cause loss of consciousness, seizures, injury, or death. Recurrent severe hypoglycemic episodes can significantly impact patients’ daily activities and quality of life.
Higher levels of post-transplant islet cell engraftment were observed with the tegoprubart-based immunosuppression regimen than in historical patients treated with a tacrolimus-based immunosuppression regimen at UChicago Medicine. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Tegoprubart-based immunosuppression was generally well tolerated, with immunosuppression-related adverse events generally successfully treated by lowering the mycophenolic acid dose, if necessary. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors such as tacrolimus.
The investigator-initiated pilot study enrolled 12 adults with long-standing T1D undergoing allogeneic islet transplantation at UChicago Medicine with a median duration of diabetes of approximately 33 years and mean HbA1c of approximately 8.0% prior to transplantation. Participants received tegoprubart, as part of a calcineurin inhibitor-free immunosuppression regimen. Calcineurin inhibitors such as tacrolimus are commonly used to prevent transplant rejection but can be associated with kidney toxicity, hypertension, neurological side effects, and harm to insulin-producing islet cells, limiting their suitability for long-term use in patients with T1D receiving an islet cell transplant.
“T1D patients have been waiting decades for a potential functional cure, and it is exciting to see the progress being made in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “For people who have difficulty managing T1D, a regimen that may protect an islet cell graft without the long-term burden associated with calcineurin inhibitors, the current standard of care, could be transformational. We are proud to support this important research effort led by Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”
“Insulin independence without the burden of traditional immunosuppression has long been one of cell replacement therapy's biggest goals,” said Aaron Kowalski, Ph.D., Chief Executive Officer of Breakthrough T1D. “Results like these show that this goal is becoming increasingly achievable. Breakthrough T1D is proud to fund this important study.”
This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.
About Islet Transplantation for Type 1 Diabetes
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. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Source: Eledon Pharmaceuticals