Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2025 Outlook
Eledon Pharmaceuticals (Nasdaq: ELDN) announced significant milestones achieved in 2024 and provided their 2025 outlook.
Key 2024 highlights include:
- Completed enrollment in the Phase 2 BESTOW trial for tegoprubart in kidney transplantation four months early, with topline results expected in Q4 2025.
- Presented data from Phase 1b trial showing tegoprubart's safety and tolerability in preventing organ rejection in kidney transplants.
- Reported positive initial data from three type 1 diabetes patients treated with tegoprubart in an islet transplantation trial at UChicago Medicine.
- Utilized tegoprubart in the first-ever kidney xenotransplant from a genetically modified pig to a human.
- Completed two financings totaling $135 million, expected to fund operations through 2026.
For 2025, Eledon plans to:
- Report updated interim data from ongoing Phase 1b and long-term efficacy studies in summer 2025.
- Release topline results from the BESTOW trial in Q4 2025.
- Provide longer-term follow-up data from the islet transplantation trial at UChicago Medicine.
Eledon Pharmaceuticals (Nasdaq: ELDN) ha annunciato traguardi significativi raggiunti nel 2024 e fornito una prospettiva per il 2025.
Le principali novità del 2024 includono:
- Completamento dell'arruolamento nel trial di Fase 2 BESTOW per il tegoprubart nel trapianto di rene quattro mesi prima del previsto, con i risultati iniziali attesi nel Q4 2025.
- Presentazione di dati dal trial di Fase 1b che mostrano la sicurezza e la tollerabilità del tegoprubart nella prevenzione del rigetto d'organo nei trapianti di rene.
- Segnalazione di dati iniziali positivi da tre pazienti con diabete di tipo 1 trattati con tegoprubart in un trial di trapianto di isole presso UChicago Medicine.
- Utilizzo del tegoprubart nel primo trapianto di rene xenogenico mai realizzato da un maiale geneticamente modificato a un essere umano.
- Completamento di due finanziamenti per un totale di 135 milioni di dollari, previsti per finanziare le operazioni fino al 2026.
Per il 2025, Eledon prevede di:
- Rimandare dati aggiornati intermedi dai trial in corso di Fase 1b e studi di efficacia a lungo termine nell'estate del 2025.
- Pubblicare i risultati preliminari del trial BESTOW nel Q4 2025.
- Fornire dati di follow-up a lungo termine dal trial di trapianto di isole presso UChicago Medicine.
Eledon Pharmaceuticals (Nasdaq: ELDN) anunció hitos significativos alcanzados en 2024 y proporcionó su perspectiva para 2025.
Los aspectos más destacados de 2024 incluyen:
- Finalización de la inscripción en el ensayo de Fase 2 BESTOW para el tegoprubart en trasplante de riñón, cuatro meses antes de lo previsto, con resultados iniciales esperados para el Q4 2025.
- Presentación de datos del ensayo de Fase 1b que muestran la seguridad y tolerabilidad del tegoprubart en la prevención del rechazo de órganos en trasplantes de riñón.
- Informe de datos iniciales positivos de tres pacientes con diabetes tipo 1 tratados con tegoprubart en un ensayo de trasplante de islotes en UChicago Medicine.
- Uso de tegoprubart en el primer trasplante de riñón xenogénico realizado de un cerdo modificado genéticamente a un humano.
- Completamiento de dos financiaciones por un total de 135 millones de dólares, que se espera financien las operaciones hasta 2026.
Para 2025, Eledon planea:
- Informar datos interinos actualizados de los estudios en curso de Fase 1b y estudios de eficacia a largo plazo en el verano de 2025.
- Publicar resultados iniciales del ensayo BESTOW en el Q4 2025.
- Proporcionar datos de seguimiento a largo plazo del ensayo de trasplante de islotes en UChicago Medicine.
엘레돈 제약 (Nasdaq: ELDN)은 2024년 성과를 발표하고 2025년 전망을 제시했습니다.
2024년 주요 성과는 다음과 같습니다:
- 테고프루바트의 신장 이식에 대한 2상 BESTOW 시험에서의 모집을 4개월 빨리 완료했으며, 2025년 4분기에 톱라인 결과가 예상됩니다.
- 신장 이식에서 장기 거부 반응을 예방하기 위해 테고프루바트의 안전성과 내약성을 보여주는 1b상 시험 데이터를 발표했습니다.
- 시카고대학 의사과학부에서의 이종 세포 이식 시험에서 테고프루바트로 치료받은 1형 당뇨병 환자 3명의 긍정적인 초기 데이터를 보고했습니다.
- 유전자 변형된 돼지에서 인간으로의 신장 이종 이식에 최초로 테고프루바트를 사용했습니다.
- 2026년까지의 운영 자금을 조달하기 위해 총 1억 3천5백만 달러의 두 번의 자금을 조달했습니다.
2025년을 위해 엘레돈은:
- 2025년 여름에 진행 중인 1b상 및 장기 효능 연구의 업데이트된 중간 데이터를 보고할 예정입니다.
- 2025년 4분기에 BESTOW 시험의 톱라인 결과를 발표할 예정입니다.
- 시카고대학 의사과학부의 이종 세포 이식 시험에서의 장기 추적 데이터를 제공할 예정입니다.
Eledon Pharmaceuticals (Nasdaq: ELDN) a annoncé des étapes importantes atteintes en 2024 et a fourni ses prévisions pour 2025.
Les faits marquants de 2024 incluent :
- Achèvement de l'inscription à l'essai de phase 2 BESTOW pour le tegoprubart dans la transplantation de rein, quatre mois plus tôt que prévu, avec des résultats préliminaires attendus au 4ème trimestre 2025.
- Présentation de données de l'essai de phase 1b montrant la sécurité et la tolérance du tegoprubart dans la prévention du rejet d'organe lors des greffes rénales.
- Rapport de résultats initiaux positifs de trois patients diabétiques de type 1 traités avec le tegoprubart dans un essai de transplantation d’îlots à UChicago Medicine.
- Utilisation du tegoprubart dans la première transplantation rénale xénogénique d'un porc génétiquement modifié à un humain.
- Finalisation de deux financements totalisant 135 millions de dollars, prévus pour financer les opérations jusqu'en 2026.
Pour 2025, Eledon prévoit de :
- Faire rapport de données intermédiaires mises à jour des études en cours de phase 1b et des études d'efficacité à long terme à l'été 2025.
- Publier les résultats préliminaires de l'essai BESTOW au 4ème trimestre 2025.
- Fournir des données de suivi à long terme de l'essai de transplantation d'îlots à UChicago Medicine.
Eledon Pharmaceuticals (Nasdaq: ELDN) kündigte bedeutende Meilensteine für 2024 an und gab einen Ausblick für 2025.
Die wichtigsten Höhepunkte aus 2024 umfassen:
- Abschluss der Rekrutierung in der Phase-2-Studie BESTOW für Tegoprubart bei Nierentransplantationen vier Monate vor dem Zeitplan, mit den erwarteten Ergebnissen im Q4 2025.
- Präsentation von Daten aus der Phase-1b-Studie, die die Sicherheit und Verträglichkeit von Tegoprubart zur Verhinderung von Organabstoßungen bei Nierentransplantationen zeigen.
- Bericht über positive erste Daten von drei Typ-1-Diabetikern, die im Rahmen einer Inseltransplantationsstudie mit Tegoprubart behandelt wurden, an der UChicago Medicine.
- Einsatz von Tegoprubart in der ersten Nierentransplantation von einem genetisch veränderten Schwein zu einem Menschen.
- Abschluss von zwei Finanzierungen in Höhe von insgesamt 135 Millionen US-Dollar, die voraussichtlich die Betriebskosten bis 2026 finanzieren werden.
Für 2025 plant Eledon:
- Aktualisierte Zwischendaten aus laufenden Phase-1b- und Langzeitwirksamkeitsstudien im Sommer 2025 zu berichten.
- Die ersten Ergebnisse der BESTOW-Studie im Q4 2025 zu veröffentlichen.
- Langfristige Nachfolgedaten aus der Inseltransplantationsstudie an UChicago Medicine bereitzustellen.
- Completed enrollment in Phase 2 BESTOW trial four months ahead of schedule.
- Presented data showing tegoprubart's safety and tolerability in Phase 1b trial.
- Reported positive initial data from islet transplantation trial for type 1 diabetes.
- Utilized tegoprubart in first-ever kidney xenotransplant.
- Completed financings of $135 million to support operations through 2026.
- None.
Insights
The completion of enrollment in the Phase 2 BESTOW trial four months ahead of schedule represents exceptional operational efficiency. The trial's 120-patient enrollment and accelerated timeline significantly de-risks the development program. Early Phase 1b data showing mean eGFR of 70.5 mL/min/1.73m2 suggests strong kidney function preservation, particularly impressive given that normal eGFR ranges from 90-120 mL/min/1.73m2.
The achievement of insulin independence in islet transplant recipients without tacrolimus is a potential paradigm shift in transplant medicine. Tacrolimus, while effective, has significant side effects including nephrotoxicity. Demonstrating efficacy without it could position tegoprubart as a revolutionary advancement in transplant immunosuppression.
The
The company's ability to secure this funding in challenging market conditions demonstrates strong institutional confidence in tegoprubart's potential. The strategic timing of multiple data readouts throughout 2025 creates multiple catalyst opportunities for potential stock price appreciation.
The successful application of tegoprubart in the groundbreaking xenotransplantation case adds a compelling dimension to its potential. Xenotransplantation could help address the severe organ shortage crisis, with over 100,000 patients currently waiting for kidney transplants in the US alone. The ability to prevent rejection in xenotransplants would represent a massive market opportunity beyond traditional transplantation.
The safety profile demonstrated thus far is particularly noteworthy, as historical anti-CD40L antibodies were plagued by thrombotic complications. Tegoprubart's clean safety profile, combined with efficacy signals across multiple transplant types, suggests potential best-in-class positioning in the transplant immunosuppression space.
Completed enrollment in Phase 2 BESTOW trial assessing tegoprubart in kidney transplantation four months ahead of schedule; on track to report topline results in fourth quarter of 2025
Presented updated data on 13 participants from ongoing Phase 1b trial that continue to support safety and tolerability of tegoprubart for prevention of organ rejection in kidney transplantation
Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine
Completed two financings totaling
IRVINE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced a summary of 2024 accomplishments and provided guidance for anticipated 2025 business milestones.
“2024 was a transformative year for Eledon as we achieved multiple key clinical milestones for tegoprubart across kidney, islet cell, and xenograft transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Moreover, the data we reported reinforced the potential of tegoprubart to be a best-in-class immunosuppression therapy to prevent transplant rejection and disrupt the current standard of care. We now look forward to another pivotal year ahead.”
2024 Key Highlights
- Completed enrollment of 120 patients in the Phase 2 BESTOW clinical trial approximately four months earlier than originally planned. The Phase 2 trial is designed to assess the safety and efficacy of tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation.
- Presented updated data at the American Transplant Congress (ATC) from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 13 participants demonstrated that tegoprubart was generally safe and well tolerated, with an overall mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m2 at all reported time points after day 30 post-transplant. Two participants completed more than 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one-year post-transplant.
- Announced positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
- Announced the use of tegoprubart as part of the immunosuppression treatment regimen used following the first-ever kidney xenotransplant procedure of a genetically modified pig kidney to a human.
- Completed two financings for combined total gross proceeds of
$135.0 million , before deducting any offering related expenses, which is anticipated to support company operations to the end of 2026.
Anticipated 2025 Milestones
- Summer 2025: Report updated interim clinical data from the ongoing Phase 1b and long-term efficacy extension studies of tegoprubart in kidney transplantation.
- 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
- 2025: Report longer-term follow up results from the investigator-led clinical trial at UChicago Medicine Transplant Institute for pancreatic islet transplantation in subjects with type 1 diabetes involving use of tegoprubart as part of immunosuppression regimen.
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 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, the company’s capital resources and ability to finance planned clinical trials, 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 sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. 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
CG Life
(212) 253 8881
jurban@cglife.com
Source: Eledon Pharmaceuticals
FAQ
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