Eledon Provides Enrollment Update for Phase 2 BESTOW Trial Assessing Tegoprubart for the Prevention of Organ Rejection
Eledon Pharmaceuticals (NASDAQ: ELDN) has reached a significant milestone in its Phase 2 BESTOW trial, enrolling 80 participants, which represents two-thirds of the projected recruitment for evaluating tegoprubart in preventing kidney transplant rejection. The multicenter study, comparing tegoprubart to tacrolimus, aims to enroll approximately 120 participants across the United States, Europe, and Latin America. The trial's primary objective is to assess graft function at 12 months post-transplant using estimated glomerular filtration rate (eGFR). Eledon's CEO, David-Alexandre C. Gros, M.D., expressed gratitude for the high level of interest and emphasized the urgency for innovative solutions in transplant rejection prevention. The company remains on track to complete enrollment by the end of the year.
Eledon Pharmaceuticals (NASDAQ: ELDN) ha raggiunto un traguardo significativo nel suo studio di Fase 2 BESTOW trial, arruolando 80 partecipanti, che rappresentano due terzi del reclutamento previsto per valutare tegoprubart nella prevenzione del rigetto del trapianto renale. Lo studio multicentrico, che confronta tegoprubart con tacrolimus, mira ad arruolare circa 120 partecipanti negli Stati Uniti, in Europa e in America Latina. L'obiettivo principale dello studio è valutare la funzione del trapianto a 12 mesi post-trapianto utilizzando il tasso di filtrazione glomerulare stimato (eGFR). Il CEO di Eledon, David-Alexandre C. Gros, M.D., ha espresso gratitudine per l'alto livello di interesse ed ha sottolineato l'urgenza di soluzioni innovative nella prevenzione del rigetto del trapianto. L'azienda è in linea per completare l'arruolamento entro la fine dell'anno.
Eledon Pharmaceuticals (NASDAQ: ELDN) ha alcanzado un hito significativo en su ensayo de Fase 2 BESTOW trial, inscribiendo a 80 participantes, lo que representa dos tercios de la contratación proyectada para evaluar tegoprubart en la prevención del rechazo del trasplante renal. El estudio multicéntrico, que compara tegoprubart con tacrolimus, tiene como objetivo inscribir a aproximadamente 120 participantes en los Estados Unidos, Europa y América Latina. El objetivo principal del ensayo es evaluar la función del injerto a los 12 meses post-trasplante utilizando la tasa de filtración glomerular estimada (eGFR). El CEO de Eledon, David-Alexandre C. Gros, M.D., expresó su agradecimiento por el alto nivel de interés y enfatizó la urgencia de soluciones innovadoras para la prevención del rechazo del trasplante. La empresa está en camino de completar la inscripción a finales de año.
Eledon Pharmaceuticals (NASDAQ: ELDN)은 BESTOW trial 2상 시험에서 중요한 이정표를 세웠으며, 80명의 참가자를 모집하여 테고프루바르트의 신장 이식 거부 반응 예방 평가를 위한 예상 모집 인원의 3분의 2를 차지합니다. 이 다기관 연구는 테고프루바르트를 타크롤리무스와 비교하며, 미국, 유럽 및 라틴 아메리카에서 약 120명의 참가자를 모집하는 것을 목표로 하고 있습니다. 이 시험의 주요 목표는 이식 후 12개월에 이식 기능을 평가하는 것이며, 이는 예상 사구체 여과율(eGFR)을 사용합니다. Eledon의 CEO인 David-Alexandre C. Gros, M.D.는 높은 관심에 감사의 뜻을 표하며 이식 거부 반응 예방을 위한 혁신적인 솔루션의 필요성을 강조했습니다. 이 회사는 연말까지 등록을 완료할 계획입니다.
Eledon Pharmaceuticals (NASDAQ: ELDN) a atteint un jalon significatif dans son essai de Phase 2 BESTOW trial, avec l'inscription de 80 participants, représentant les deux tiers du recrutement prévu pour évaluer tegoprubart dans la prévention du rejet de greffe rénale. L'étude multicentrique, comparant tegoprubart à tacrolimus, vise à recruter environ 120 participants aux États-Unis, en Europe et en Amérique Latine. L'objectif principal de l'essai est d'évaluer la fonction de la greffe à 12 mois post-greffe en utilisant le taux de filtration glomérulaire estimé (eGFR). Le PDG d'Eledon, David-Alexandre C. Gros, M.D., a exprimé sa gratitude pour le niveau élevé d'intérêt et a souligné l'urgence de solutions innovantes en matière de prévention du rejet de greffe. L'entreprise reste sur la bonne voie pour terminer le recrutement d'ici la fin de l'année.
Eledon Pharmaceuticals (NASDAQ: ELDN) hat einen bedeutenden Meilenstein in seiner Phase-2-Studie BESTOW trial erreicht und 80 Teilnehmer eingeschrieben, was zwei Drittel der geplanten Rekrutierung zur Bewertung von tegoprubart zur Prävention von Nierentransplantatabstoßungen darstellt. Die multizentrische Studie, die tegoprubart mit Tacrolimus vergleicht, strebt an, etwa 120 Teilnehmer in den Vereinigten Staaten, Europa und Lateinamerika einzuschreiben. Das Hauptziel des Trials ist die Bewertung der Transplantatfunktion nach 12 Monaten post-Transplantation unter Verwendung der geschätzten glomerulären Filtrationsrate (eGFR). Eledons CEO, David-Alexandre C. Gros, M.D., drückte seine Dankbarkeit für das hohe Interesse aus und betonte die Dringlichkeit innovativer Lösungen zur Vorbeugung von Transplantatabstoßung. Das Unternehmen liegt im Zeitplan, um die Rekrutierung bis Ende des Jahres abzuschließen.
- Enrollment of 80 participants (two-thirds of projected recruitment) in Phase 2 BESTOW trial
- On track to complete enrollment by the end of the year
- High level of interest from participants and clinical teams
- Multicenter study across United States, Europe, and Latin America
- None.
Insights
Eledon Pharmaceuticals' announcement of reaching 80 participants in their Phase 2 BESTOW trial for tegoprubart is a significant milestone in kidney transplant research. This represents two-thirds of the projected 120 participants, indicating strong progress and interest in the study.
The trial's focus on comparing tegoprubart, an anti-CD40 ligand antibody, to tacrolimus, a standard calcineurin inhibitor, is particularly noteworthy. The primary endpoint of graft function at 12 months post-transplant, measured by estimated glomerular filtration rate (eGFR), is a important metric. Higher eGFR values correlate with better long-term patient and graft survival, which could potentially revolutionize kidney transplant outcomes if tegoprubart proves superior.
However, it's important to note that Phase 2 trials primarily assess safety and early signs of efficacy. While promising, the results will need to be confirmed in larger Phase 3 trials before any definitive conclusions can be drawn about tegoprubart's effectiveness compared to current standard-of-care treatments.
The multi-national nature of the study, spanning the United States, Europe and Latin America, adds strength to its design by potentially increasing the diversity of the patient population and the generalizability of results.
Eledon Pharmaceuticals' progress in the BESTOW trial is a positive indicator for the company's pipeline development. Achieving two-thirds enrollment ahead of schedule suggests strong execution capabilities and could potentially lead to earlier-than-expected trial completion and data readout.
For investors, this progress reduces some of the clinical development risk associated with Eledon's lead asset, tegoprubart. However, it's important to remember that success in Phase 2 doesn't guarantee Phase 3 success or eventual FDA approval.
Financially, faster enrollment could potentially lead to cost savings in the long run, as prolonged recruitment periods often increase trial expenses. This efficiency might positively impact Eledon's cash runway, a critical factor for clinical-stage biotech companies.
It's worth noting that Eledon is running multiple trials for tegoprubart in kidney transplantation, including a Phase 1b and a long-term safety study. This comprehensive approach could provide a robust data package for future regulatory submissions, potentially strengthening the company's position in the transplant market if the drug proves successful.
While this news is encouraging, investors should remain cautious. Eledon's market cap and stock price will likely remain volatile and highly dependent on future clinical results and the company's ability to finance its operations through to potential commercialization.
80 Participants (Two-thirds of Projected Recruitment) Enrolled
IRVINE, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation.
“As of this week, we have already enrolled two-thirds of the projected study participants across sites in the United States, Europe and Latin America,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We are grateful to the participants and their clinical teams, whose high level of interest enabled us to achieve this level of enrollment in our Phase 2 BESTOW trial. This progress underscores the urgency and need for innovative solutions in preventing kidney transplant rejection. We remain on track to complete enrollment by the end of the year.”
BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart 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. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival.
Eledon is currently conducting a Phase 2 trial (BESTOW; NCT05983770), a 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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