Eledon Reports Preliminary Data from First Six Patients with Type 1 Diabetes Treated with Tegoprubart as the Core Immunosuppressant Following Islet Transplantation in Investigator-Initiated Trial at UChicago Medicine
Eledon (NASDAQ: ELDN) reported preliminary results from the first six type 1 diabetes patients in an investigator-initiated islet transplant trial using tegoprubart as the core tacrolimus-free immunosuppressant.
All six subjects achieved and maintained insulin independence after one or two transplants; three patients have been insulin-free >15 months, one reached HbA1c 4.7% for >15 months, two patients reached insulin independence ≈4 weeks post-transplant with HbA1c <6% for >3 months, and a sixth is insulin-free with HbA1c 5.3%. No serious infections, thromboembolic events, rejection events, or kidney/neurologic toxicities were reported.
Eledon (NASDAQ: ELDN) ha riportato risultati preliminari dai primi sei pazienti con diabete di tipo 1 in uno studio di trapianto di isole condotto dall'investigatore, usando tegoprubart come immunosoppressore privo di tacrolimus.
Tutti e sei i soggetti hanno ottenuto e mantenuto l'indipendenza insulinica dopo uno o due trapianti; tre pazienti sono senza insulina da oltre 15 mesi, uno ha raggiunto HbA1c 4,7% per oltre 15 mesi, due pazienti hanno raggiunto l'indipendenza insulinica circa 4 settimane dopo il trapianto con HbA1c <6% per oltre 3 mesi, e un sesto è senza insulina con HbA1c 5,3%. Non sono stati riportati infezioni gravi, eventi tromboembolici, episodi di rigetto o tossicità renale/neuronale.
Eledon (NASDAQ: ELDN) informó resultados preliminares de los primeros seis pacientes con diabetes tipo 1 en un ensayo de trasplante de islotes iniciado por el investigador, utilizando tegoprubart como inmunosupresor central sin tacrolimus.
Los seis sujetos lograron y mantuvieron la independencia de insulina tras uno o dos trasplantes; tres pacientes llevan sin insulina más de 15 meses, uno alcanzó HbA1c 4,7% durante más de 15 meses, dos pacientes alcanzaron la independencia de insulina aproximadamente 4 semanas después del trasplante con HbA1c <6% durante más de 3 meses, y un sexto es sin insulina con HbA1c 5,3%. No se reportaron infecciones graves, eventos tromboembólicos, rechazo o toxicidad renal/neurológica.
Eledon (NASDAQ: ELDN)은 연구자가 주도한 제1형 당뇨병 환자 6명을 대상으로 한 섬오가 이식 시험의 예비 결과를 보고했으며, 핵심 면역억제제인 tegoprubart를 tacrolimus 없이 사용했습니다.
모두 6명의 피실험자는 한 차례 또는 두 차례의 이식 수술 후 인슀린 의존성으로부터 해방되었고, 그 중 3명은 15개월 이상 인슀린 없이 지냈으며, 한 명은 15개월 이상 HbA1c 4.7%를 달성했고, 두 명은 이식 후 약 4주 만에 인슀린 의존성 해방을 달성하고 HbA1c가 3개월 이상 6% 미만으로 유지되었으며, 다섯 번째는 HbA1c 5.3%로 인슀린 없이 지냅니다. 심각한 감염, 혈전성 합병증, 거부 반응 또는 신장/신경독성은 보고되지 않았습니다.
Eledon (NASDAQ: ELDN) a publié des résultats préliminaires sur les six premiers patients atteints de diabète de type 1 dans un essai de transplantation d’îlots initié par les chercheurs, en utilisant tegoprubart comme immunosuppresseur central sans tacrolimus.
Les six sujets ont atteint et maintenu l’indépendance insulinique après un ou deux transplantes ; trois patients sont sans insulin depuis plus de 15 mois, un a atteint HbA1c 4,7% pendant plus de 15 mois, deux patients ont atteint l’indépendance insulinique environ 4 semaines après la transplantation avec HbA1c <6% pendant plus de 3 mois, et un sixième est sans insulinémie avec HbA1c 5,3%. Aucune infection grave, aucun événement thromboembolique, rejet ou toxicité rénale/neurologique n’a été rapporté.
Eledon (NASDAQ: ELDN) meldete vorläufige Ergebnisse von den ersten sechs Typ-1-Diabetes-Patienten in einer vom Prüfer initiierten Insel-Island-Transplantation-Studie, bei der tegoprubart als zentraler tacrolimus-freier Immunosuppressans verwendet wurde.
Alle sechs Probanden erreichten und hielten die Insulinunabhängigkeit nach ein oder zwei Transplantationen; drei Patienten sind seit über 15 Monaten insulinfrei, einer erreichte HbA1c 4,7% über mehr als 15 Monate, zwei Patienten erreichten die Insulinunabhängigkeit ca. 4 Wochen nach der Transplantation mit HbA1c <6% über mehr als 3 Monate, und ein Sechster ist insulinfrei mit HbA1c 5,3%. Es wurden keine schweren Infektionen, thromboembolische Ereignisse, Abstoßungsreaktionen oder nephro-/neurologische Toxizitäten berichtet.
إيلدون (بورصة ناسداك: ELDN) أبلغت عن نتائج ابتدائية من أول ستة مرضى مصابين بالسكري من النوع 1 في تجربة زرع عُصَيّاتٍ جُزئية تقودها الجهة البحثية باستخدام tegoprubart كمثبط مناعي خالٍ من التاكروليم.
حقق جميع الستة مشاركين واستمروا في الاعتماد على أنفسهم بالأنسولين بعد عملية زرع واحدة أو اثنتين؛ ثلاثة مرضى بلا أنسولين لأكثر من 15 شهراً، واحد وصل HbA1c 4.7% لأكثر من 15 شهراً، مرضيان وصلا إلى الاستقلال عن الأنسولين تقريباً خلال 4 أسابيع من الزرع مع HbA1c <6% لأكثر من 3 أشهر، والرابع بلا أنسولين مع HbA1c 5.3%. لم تُبلَّغ عن عدوى خطيرة، أو أحداث خثارية/إقفارية، أو رفض زراعي، أو سمية كلوية/عصبية.
- All six patients achieved insulin independence
- One patient maintained HbA1c 4.7% for over 15 months
- Two patients reached insulin independence ≈4 weeks post-transplant
- All six patients free of severe hypoglycemia since transplant
- No serious infections, thromboembolic, rejection, kidney, or neurologic toxicity reported
- Data are preliminary from only six patients
- Trial extended to 12 subjects, pending additional outcome data
- No randomized control or long-term safety database presented
Insights
Preliminary six-patient data show tegoprubart enabled sustained insulin independence after islet transplant without calcineurin inhibitors.
The data indicate that using tegoprubart as the core immunosuppressant allowed all six treated subjects to achieve and maintain insulin independence following one or two islet transplants, with reported HbA1c values as low as
These observations describe a clear therapeutic mechanism: an anti-CD40L antibody replacing calcineurin inhibition to permit islet engraftment and function while apparently avoiding certain toxicities. The main dependencies and risks are sample size and follow-up length; results from six subjects and short follow-up for some participants limit confidence in durability and generalisability. Important, monitor enrollment expansion to 12 subjects, formal safety endpoints, any reported rejection events, and persistence of insulin independence at standard milestone intervals (for example, 12 and 24 months) and the second planned funded study; relevant timeframes are the trial extension to 12 subjects and ongoing follow-up through the reported >15-month observation for early participants.
IRVINE, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today 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 (anti-CD40L) antibody, as the core of a tacrolimus-free immunosuppression drug regimen for the prevention of islet transplant rejection in individuals with type 1 diabetes (T1D). The results, presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, 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 (HbA1c) 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
“For years, clinicians have been working to find a new medication that can prevent rejection of islet cells while offering a better safety profile than calcineurin inhibitors including tacrolimus, which remain the current standard of care but are often associated with debilitating metabolic, neurologic, and cardiovascular toxicities,” said Dr. Witkowski. “These preliminary data in the first six subjects with T1D as part of our UChicago Medicine clinical trial are very encouraging, with all six subjects achieving insulin independence, and suggest that tegoprubart may be the innovative immunosuppression therapy we need to transform islet transplantation in the years ahead.”
“Breakthrough T1D continues to be encouraged by the data from the investigational use of tegoprubart as a novel immunosuppression alternative to advance islet transplantation,” said Esther Latres, Ph.D., Breakthrough T1D Senior Vice President, Research. “We look forward to continuing to support this promising research and to more data on tegoprubart in islet transplants in the future.”
This clinical trial is funded by Breakthrough T1D (formerly JDRF), 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. Post-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, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
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.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com
Source: Eledon Pharmaceuticals
FAQ
What did Eledon (ELDN) report about tegoprubart in the UChicago islet transplant trial on November 18, 2025?
How quickly did patients reach insulin independence in the ELDN tegoprubart trial?
What HbA1c outcomes did Eledon report for ELDN patients treated with tegoprubart?
Were any safety issues reported with tegoprubart in the ELDN investigator trial?
How many patients will the ELDN/UChicago investigator-initiated trial include?
Who is funding the tegoprubart islet transplant trial involving Eledon (ELDN)?
