Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation
Eledon Pharmaceuticals (NASDAQ: ELDN) presented updated data from its ongoing Phase 1b trial of tegoprubart for kidney transplant rejection prevention. The trial showed promising results with patients maintaining an average 12-month eGFR of 68 mL/min/1.73 m², significantly higher than the historical standard of care average of 53 mL/min/1.73 m².
The study enrolled 32 patients, with preliminary iBox data suggesting tegoprubart may achieve over 96% predicted 5-year allograft survival rate. The drug demonstrated strong safety profile with no deaths, graft loss, drug-related tremor, or new-onset diabetes. While six rejection episodes occurred, all were successfully treated, with patients remaining on tegoprubart showing superior kidney function recovery compared to those who switched to standard care.
The company expects topline results from its Phase 2 BESTOW trial in November 2025.Eledon Pharmaceuticals (NASDAQ: ELDN) ha presentato dati aggiornati dal suo trial in corso di Fase 1b su tegoprubart per la prevenzione del rigetto del trapianto renale. Lo studio ha mostrato risultati promettenti con pazienti che hanno mantenuto un eGFR medio a 12 mesi di 68 mL/min/1,73 m², significativamente superiore rispetto alla media storica standard di 53 mL/min/1,73 m².
Lo studio ha coinvolto 32 pazienti, con dati preliminari iBox che suggeriscono che tegoprubart potrebbe raggiungere un tasso di sopravvivenza dell'allo trapianto previsto a 5 anni superiore al 96%. Il farmaco ha mostrato un profilo di sicurezza solido senza decessi, perdita del trapianto, tremori correlati al farmaco o insorgenza di diabete. Nonostante si siano verificati sei episodi di rigetto, tutti sono stati trattati con successo, e i pazienti che sono rimasti in trattamento con tegoprubart hanno mostrato un recupero della funzione renale superiore rispetto a quelli passati alla terapia standard.
L'azienda prevede i risultati principali del suo trial di Fase 2 BESTOW per novembre 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) presentó datos actualizados de su ensayo en curso de Fase 1b con tegoprubart para la prevención del rechazo en trasplante renal. El ensayo mostró resultados prometedores con pacientes manteniendo un eGFR promedio a 12 meses de 68 mL/min/1,73 m², significativamente superior al promedio histórico estándar de 53 mL/min/1,73 m².
El estudio incluyó a 32 pacientes, con datos preliminares de iBox que sugieren que tegoprubart podría alcanzar una tasa de supervivencia del aloinjerto predicha a 5 años superior al 96%. El fármaco demostró un perfil de seguridad sólido sin muertes, pérdida del injerto, temblores relacionados con el medicamento ni diabetes de nueva aparición. Aunque ocurrieron seis episodios de rechazo, todos fueron tratados con éxito, y los pacientes que continuaron con tegoprubart mostraron una recuperación de la función renal superior en comparación con quienes cambiaron a la atención estándar.
La compañía espera resultados principales de su ensayo de Fase 2 BESTOW en noviembre de 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN)은 신장 이식 거부 반응 예방을 위한 tegoprubart의 진행 중인 1b상 시험에서 업데이트된 데이터를 발표했습니다. 시험 결과, 환자들은 평균 12개월 eGFR 68 mL/min/1.73 m²를 유지하여 과거 표준 치료 평균인 53 mL/min/1.73 m²보다 유의하게 높았습니다.
연구에는 32명의 환자가 등록되었으며, 예비 iBox 데이터는 tegoprubart가 예상 5년 이식편 생존율 96% 이상을 달성할 수 있음을 시사합니다. 약물은 사망, 이식편 손실, 약물 관련 떨림 또는 신생 당뇨 없이 강력한 안전성을 보였습니다. 6건의 거부 반응이 있었으나 모두 성공적으로 치료되었으며, tegoprubart를 계속 투여받은 환자들은 표준 치료로 전환한 환자들보다 신장 기능 회복이 우수했습니다.
회사는 2025년 11월에 2상 BESTOW 시험의 주요 결과를 기대하고 있습니다.
Eledon Pharmaceuticals (NASDAQ : ELDN) a présenté des données mises à jour de son essai de phase 1b en cours sur le tegoprubart pour la prévention du rejet de greffe rénale. L'essai a montré des résultats prometteurs avec des patients maintenant un DFGe moyen à 12 mois de 68 mL/min/1,73 m², nettement supérieur à la moyenne historique des soins standards de 53 mL/min/1,73 m².
L'étude a inclus 32 patients, avec des données préliminaires iBox suggérant que le tegoprubart pourrait atteindre un taux de survie du greffon prédit à 5 ans supérieur à 96%. Le médicament a démontré un profil de sécurité solide sans décès, perte du greffon, tremblements liés au médicament ou diabète de novo. Bien que six épisodes de rejet aient eu lieu, tous ont été traités avec succès, les patients restant sous tegoprubart montrant une récupération de la fonction rénale supérieure à celle des patients passés aux soins standards.
La société prévoit les résultats principaux de son essai de phase 2 BESTOW en novembre 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) präsentierte aktualisierte Daten aus der laufenden Phase-1b-Studie zu Tegoprubart zur Verhinderung von Nierentransplantatabstoßung. Die Studie zeigte vielversprechende Ergebnisse, wobei die Patienten eine durchschnittliche 12-Monats-eGFR von 68 mL/min/1,73 m² aufwiesen, was deutlich über dem historischen Standard von 53 mL/min/1,73 m² liegt.
Die Studie umfasste 32 Patienten, und vorläufige iBox-Daten deuten darauf hin, dass Tegoprubart eine voraussichtliche 5-Jahres-Allograft-Überlebensrate von über 96% erreichen könnte. Das Medikament zeigte ein starkes Sicherheitsprofil ohne Todesfälle, Transplantatverlust, medikamentenbedingtes Zittern oder neu auftretenden Diabetes. Obwohl sechs Abstoßungsereignisse auftraten, wurden alle erfolgreich behandelt, und Patienten, die Tegoprubart weiter erhielten, zeigten eine überlegene Erholung der Nierenfunktion im Vergleich zu denen, die auf die Standardtherapie wechselten.
Das Unternehmen erwartet die Hauptergebnisse seiner Phase-2-BESTOW-Studie im November 2025.
- Superior kidney function maintenance with eGFR of 68 mL/min/1.73 m² vs 53 mL/min/1.73 m² for standard care
- Predicted 5-year allograft survival rate over 96%, suggesting better long-term outcomes
- Strong safety profile with no deaths, graft loss, or serious complications
- Successful treatment of all rejection episodes with superior recovery in tegoprubart patients
- 18.8% rejection episode rate (6 cases) observed in the trial
- 75% of rejection cases occurred in patients with low-dose rATG induction
- Patients switching to standard care showed poor kidney function recovery (34 mL/min/1.73 m²)
Insights
Eledon's tegoprubart shows promising kidney function preservation with fewer side effects than standard transplant medications, boosting its market potential.
Eledon's Phase 1b data for tegoprubart in kidney transplantation demonstrates impressive clinical outcomes that could potentially reshape the transplant immunosuppression landscape. The 12-month eGFR of
The preliminary iBox score data is particularly significant. With scores of -3.75 (intention-to-treat) and -4.11 (on-treatment) compared to -2.98 for standard therapy, tegoprubart may improve 5-year graft survival rates to over
The safety profile remains compelling with no cases of drug-related tremor or new-onset diabetes – both common complications with tacrolimus. While the
These results reinforce the CD40L pathway as a promising target for transplant immunosuppression. With Phase 2 BESTOW trial results expected in November, tegoprubart could potentially address the critical unmet need for immunosuppressive regimens that provide adequate rejection protection without the nephrotoxicity and metabolic complications of current options.
Data from patients who remained on tegoprubart for a year showed overall mean 12-month eGFR of approximately 68 mL/min/1.73 m² post-transplant
Preliminary iBox data, a key biomarker of kidney function and immunologic response, supports that tegoprubart may improve 5-year graft survival vs. current standard of care
Tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes
Conference call to be held today at 4:30 p.m. ET
IRVINE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated data from the Company’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the oral presentation, titled “Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study,” were presented today at the World Transplant Congress (WTC) taking place in San Francisco, CA.
“The data presented today at WTC further reinforce our belief that tegoprubart has the potential to not only provide better protection and long-term preservation of kidney function following transplantation, but also to offer a safer alternative to traditional immunosuppressive therapies by minimizing harmful side effects,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The continued strength of the Phase 1b data through 12 months of treatment is highly encouraging as we look ahead to topline results from our Phase 2 BESTOW trial, expected in November, which compares tegoprubart to tacrolimus, the current standard of care.”
As of the July 2025 cutoff date, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study. Updated data showed that kidney function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for patients (n=12) who remained on tegoprubart. Kidney function in the intention-to-treat population (n=15) was approximately 63 mL/min/1.73 m2 at 12 months. Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant.
In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve 5-year graft survival. Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function (eGFR, proteinuria) and immunologic response (donor-specific antibodies) parameters into a single prognostic score. Based on data collected to date, abbreviated iBox scores were -3.75 in the intention-to-treat population and -4.11 in the on-treatment population, which compare favorably to a -2.98 historical mean for calcineurin inhibitors. A difference in abbreviated iBox score of -0.40 at 12 months is considered predictive of a 4
Mean tegoprubart treatment exposure to date was 233 days. Tegoprubart continues to be well-tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes, a side effect associated with standard of care immunosuppression therapy.
There were six (
All 32 patients received rATG induction therapy and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids.
- Cohort 1 has completed enrollment and evaluated tegoprubart at a dose of 20 mg/kg with rATG induction up to 6 mg/kg.
- Cohort 2 is currently enrolling and is evaluating a lower tegoprubart dose of 10 mg/kg, with a required rATG dose of 4.5 mg/kg.
- The primary endpoint of the study is safety and pharmacokinetics. Secondary and exploratory endpoints include patient and graft survival, biopsy-proven acute rejection, kidney function as measured by estimated by eGFR, and abbreviated iBox score.
Eledon is also conducting a Phase 2 trial (BESTOW; NCT05983770) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Topline results from the Phase 2 BESTOW trial are anticipated in November 2025.
Full details of the WTC oral presentation are below:
Title: Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study
Session: Oral Presentation, Kidney Novel Immunosuppressant Strategies
Presenter: John Gill, MD, MS, University of British Columbia, Vancouver, Canada
Session Date and Time: Wednesday, August 6, 2025: 10:00 a.m. – 11:15 a.m. PT
Conference Call
Eledon will hold a conference call today, August 6, 2025 at 4:30 p.m. Eastern Time to discuss the updated Phase 1b trial results. To join the conference call, please dial 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. The conference ID is 34575. Registration for the live webcast can be found here and available on the “Events” section of Eledon’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
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.
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About iBox
iBox is a composite biomarker panel developed by the Paris Transplant Group to predict long-term kidney graft survival. It combines kidney function (eGFR, proteinuria), immunologic response (donor-specific antibodies), and histopathology (Banff scores) into a single prognostic score. Validated across four independent cohorts, including two Phase 3 trials (BMS BENEFIT and BENEFIT-EXT), iBox has demonstrated strong predictive accuracy (C-statistic >0.8) for 5-year graft loss and outperforms traditional markers like biopsy-proven acute rejection. Both full and abbreviated iBox models have been qualified by the European Medicines Agency (EMA) and accepted by the U.S. FDA into the Biomarker Qualification Program. The iBox Composite Biomarker Panel is under review by the FDA as a Reasonably Likely Surrogate Endpoint (RLSE) for use as a co-primary endpoint in Phase 2/3 trials, supporting potential accelerated approval of novel immunosuppressive therapies. This makes iBox the first transplant-specific endpoint formally recognized under FDA’s biomarker qualification framework.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about ongoing clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney 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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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
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