Eledon Announces Completion of Enrollment in Phase 2 BESTOW Clinical Trial Assessing Tegoprubart for Prevention of Organ Rejection in Kidney Transplant Patients
Eledon Pharmaceuticals (NASDAQ: ELDN) has announced the early completion of enrollment for its Phase 2 BESTOW clinical trial, evaluating tegoprubart for preventing organ rejection in kidney transplant patients. The trial reached its target of 120 participants four months ahead of schedule, reflecting strong interest in innovative therapies. This multicenter, two-arm study compares tegoprubart to tacrolimus, with the primary objective of assessing graft function at 12 months post-transplant. Top-line results are now expected in Q4 2025.
The accelerated enrollment builds on promising results from Eledon's ongoing Phase 1b trial presented at the American Transplant Congress in June 2024. Tegoprubart aims to provide a safer alternative to calcineurin inhibitors, which often cause side effects. Eledon is conducting multiple trials to establish tegoprubart as a new standard in immunosuppression therapy for organ transplant patients.
Eledon Pharmaceuticals (NASDAQ: ELDN) ha annunciato il completamento anticipato dell'arruolamento per il suo trial clinico di Fase 2 BESTOW, che valuta tegoprubart per prevenire il rigetto d'organo nei pazienti sottoposti a trapianto di rene. Lo studio ha raggiunto il suo obiettivo di 120 partecipanti con quattro mesi di anticipo, riflettendo un forte interesse per le terapie innovative. Questo studio multicentrico e a due bracci confronta tegoprubart con tacrolimus, con l'obiettivo principale di valutare la funzione del trapianto a 12 mesi dopo l'intervento. I risultati principali sono ora attesi per il Q4 2025.
Il reclutamento accelerato si basa su risultati promettenti del trial di Fase 1b in corso di Eledon presentati al Congresso Americano di Trapianto nel giugno 2024. Tegoprubart mira a fornire un'alternativa più sicura agli inibitori della calcineurina, che spesso causano effetti collaterali. Eledon sta conducendo diversi trial per stabilire tegoprubart come nuovo standard nella terapia immunosoppressiva per i pazienti trapiantati.
Eledon Pharmaceuticals (NASDAQ: ELDN) ha anunciado el completamiento anticipado de la inscripción para su ensayo clínico de Fase 2 BESTOW, que evalúa tegoprubart para prevenir el rechazo de órganos en pacientes de trasplante de riñón. El ensayo alcanzó su objetivo de 120 participantes cuatro meses antes de lo previsto, reflejando un gran interés por terapias innovadoras. Este estudio multicéntrico y de dos brazos compara tegoprubart con tacrolimus, con el objetivo principal de evaluar la función del injerto a los 12 meses post-trasplante. Se esperan ahora resultados preliminares para el cuarto trimestre de 2025.
La aceleración del reclutamiento se basa en resultados prometedores del ensayo de Fase 1b en curso de Eledon que se presentó en el Congreso Americano de Trasplante en junio de 2024. Tegoprubart tiene como objetivo proporcionar una alternativa más segura a los inhibidores de calcineurina, que a menudo causan efectos secundarios. Eledon está llevando a cabo múltiples ensayos para establecer tegoprubart como un nuevo estándar en la terapia inmunosupresora para pacientes de trasplante de órganos.
Eledon Pharmaceuticals (NASDAQ: ELDN)는 신장 이식 환자에서 장기 거부 반응을 예방하기 위한 tegoprubart의 임상 시험인 Fase 2 BESTOW에서 참여자 모집을 조기 완료했다고 발표했습니다. 이 시험은 예정보다 4개월 빨리 120명의 참여자 목표를 달성했습니다, 이는 혁신 치료에 대한 강한 관심을 반영합니다. 이 다기관, 두 그룹의 연구는 12개월 후 이식 기능을 평가하는 주요 목표로 tegoprubart와 tacrolimus를 비교합니다. 주요 결과는 2025년 4분기에 발표될 예정입니다.
가속화된 모집은 2024년 6월 미국 이식 학회에서 발표된 Eledon의 현재 진행 중인 Fase 1b 시험의 유망한 결과를 기반으로 합니다. Tegoprubart는 종종 부작용을 초래하는 칼시뉴린 억제제에 대한 더 안전한 대안을 제공하는 것을 목표로 합니다. Eledon은 장기 이식 환자를 위한 면역 억제 치료의 새로운 기준으로 tegoprubart를 설정하기 위해 여러 시험을 진행하고 있습니다.
Eledon Pharmaceuticals (NASDAQ: ELDN) a annoncé le complément anticipé de l'inscription pour son essai clinique de Phase 2 BESTOW, évaluant tegoprubart pour prévenir le rejet d'organe chez les patients ayant reçu une transplantation rénale. L'essai a atteint son objectif de 120 participants avec quatre mois d'avance, reflétant un fort intérêt pour les thérapies innovantes. Cette étude multicentrique à deux bras compare tegoprubart à tacrolimus, avec pour objectif principal d'évaluer la fonction de la greffe 12 mois après la transplantation. Les résultats principaux sont désormais attendus pour le quatrième trimestre 2025.
L'accélération du recrutement repose sur des résultats prometteurs de l'essai de Phase 1b en cours d'Eledon présenté au Congrès Américain de Transplantation en juin 2024. Tegoprubart vise à fournir une alternative plus sûre aux inhibiteurs de calcineurine, qui provoquent souvent des effets secondaires. Eledon mène plusieurs essais pour établir tegoprubart comme nouvelle norme dans la thérapie immunosuppressive pour les patients ayant reçu une transplantation d'organe.
Eledon Pharmaceuticals (NASDAQ: ELDN) hat die vorzeitige Beendigung der Rekrutierung für seine Phase-2-Studie BESTOW bekannt gegeben, die tegoprubart zur Verhinderung von Organabstoßung bei Nierentransplantationspatienten bewertet. Die Studie erreichte ihr Ziel von 120 Teilnehmern vier Monate vor dem Zeitplan, was das starke Interesse an innovativen Therapien widerspiegelt. Diese multizentrische, zweigeteilte Studie vergleicht tegoprubart mit Tacrolimus, wobei das Hauptziel darin besteht, die Transplantatfunktion 12 Monate nach der Transplantation zu bewerten. Die Ergebnisse sind nun im vierten Quartal 2025 zu erwarten.
Die beschleunigte Rekrutierung basiert auf vielversprechenden Ergebnissen aus Eledons laufender Phase-1b-Studie, die im Juni 2024 auf dem American Transplant Congress vorgestellt wurde. Tegoprubart zielt darauf ab, eine sicherere Alternative zu Calcineurininhibitoren zu bieten, die häufig Nebenwirkungen verursachen. Eledon führt mehrere Studien durch, um tegoprubart als neuen Standard in der immunsuppressiven Therapie für Patienten mit Organtransplantationen zu etablieren.
- Completed enrollment for Phase 2 BESTOW trial 4 months ahead of schedule
- Strong interest from clinicians and patients in tegoprubart as a potential improvement over current immunosuppression regimens
- Anticipating top-line results for BESTOW trial in Q4 2025, earlier than initially planned
- Potential to offer a safer alternative to calcineurin inhibitors for kidney transplant recipients
- None.
The early completion of enrollment for Eledon's Phase 2 BESTOW trial is a significant milestone in the development of tegoprubart. This accelerated timeline suggests strong interest from both clinicians and patients, potentially indicating a high unmet need in kidney transplant immunosuppression.
The trial's focus on graft function at 12 months post-transplant, measured by eGFR, is a crucial endpoint. Improved eGFR is associated with better long-term graft survival, which could translate to meaningful clinical benefits for patients if tegoprubart proves effective.
The comparison to tacrolimus, a current standard of care, positions tegoprubart to potentially address known side effects of calcineurin inhibitors. If successful, this could represent a significant advancement in transplant medicine, offering a new option with potentially improved safety profile.
Eledon's announcement of early enrollment completion is a positive indicator for the company's operational efficiency and the market's interest in tegoprubart. This 4-month acceleration in the trial timeline could potentially lead to earlier market entry if the drug proves successful, providing a competitive advantage.
The kidney transplant market is substantial, with over
Eledon's focus on innovation in an area that has seen little change in decades could position them well if tegoprubart shows positive results. This could lead to increased investor interest and potential partnership opportunities with larger pharmaceutical companies.
Enrollment Completed Four Months Ahead of Schedule
IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has successfully completed enrollment for its Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of its investigational immunosuppression therapy tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target enrollment of 120 participants approximately four months earlier than originally planned.
“We are very pleased to achieve this critical milestone ahead of schedule in our BESTOW trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The accelerated pace of enrollment reflects the strong interest among both clinicians and patients in new innovative therapies that have the potential to improve outcomes in kidney transplantation compared to current standard of care immunosuppression regimens. We are proud to be leading the effort to transform the prevention of organ rejection and based on the early completion of enrollment, we now anticipate reporting top-line results for the BESTOW trial in the fourth quarter of 2025.”
BESTOW, a multicenter, two-arm, active comparator clinical study, enrolled 120 participants undergoing kidney transplantation at sites in North America, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart, an anti-CD40 ligand antibody, compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Research has shown that better graft function as assessed by eGFR has been associated with improved long-term graft survival following kidney transplantation.
“Completing enrollment in the Phase 2 BESTOW trial is a significant achievement for our team and, more importantly, for the transplant community,” said Steve Perrin, Ph.D., Chief Scientific Officer and President of Eledon. “It is a testament to the strong collaboration with our clinical sites and the enthusiasm within the community for advances in immunosuppression therapy, an area of research that has not seen major therapeutic innovation in decades. We are deeply grateful to the patients, their families, and the clinical teams for their continued support in advancing this important study.”
The BESTOW trial builds upon results from Eledon’s ongoing Phase 1b trial presented at the American Transplant Congress (ATC) in June 2024, and further demonstrates that tegoprubart has the potential to provide kidney transplant recipients with a safe and effective alternative to calcineurin inhibitors, which are often associated with side effects such as hyperglycemia, new onset diabetes, hypertension, or tremors. Eledon plans to continue advancing its tegoprubart clinical program with the goal of offering a new standard of care immunosuppression therapy for organ transplant patients.
Eledon is currently conducting the Phase 2 BESTOW trial (NCT05983770), the Phase 1b trial (NCT05027906), 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.
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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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 planned 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.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com
Source: Eledon Pharmaceuticals
FAQ
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