Eledon Completes Enrollment in Phase 2 BESTOW Trial for Tegoprubart in Kidney Transplants

Eledon Pharmaceuticals, Inc. has announced the successful completion of enrollment for its Phase 2 BESTOW clinical trial. The trial, which aims to evaluate the safety and efficacy of tegoprubart, an investigational immunosuppression therapy, in preventing organ rejection in kidney transplant patients, met its target enrollment of 120 participants four months ahead of schedule.

David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon, expressed satisfaction with this milestone, attributing the accelerated enrollment pace to the strong interest from clinicians and patients in innovative therapies that promise better outcomes compared to current immunosuppression regimens. Gros anticipates reporting the trial's top-line results in the fourth quarter of 2025.

The BESTOW trial is a multicenter, two-arm, active comparator clinical study involving 120 participants undergoing kidney transplantation across sites in North America, Europe, and Latin America. The trial aims to compare the safety, pharmacokinetics, and efficacy of tegoprubart, an anti-CD40 ligand antibody, against the calcineurin inhibitor tacrolimus. A primary objective of the study is to evaluate graft function 12 months post-transplant, measured by the estimated glomerular filtration rate (eGFR). Improved eGFR correlates with better long-term graft survival, making this a crucial metric.

Steve Perrin, Ph.D., Chief Scientific Officer and President of Eledon, highlighted the importance of this achievement for both the team and the transplant community. He noted the strong collaboration with clinical sites and the community's enthusiasm for advancements in immunosuppression therapy, an area that has seen little innovation over recent decades. Perrin expressed gratitude to the patients, their families, and the clinical teams for their support.

The ongoing Phase 1b trial results presented at the American Transplant Congress (ATC) in June 2024 corroborate tegoprubart's potential in providing a safer and more effective alternative to calcineurin inhibitors for kidney transplant recipients. These inhibitors are often linked to side effects like hyperglycemia, new-onset diabetes, hypertension, or tremors. Eledon aims to continue advancing the tegoprubart clinical program, with the goal of establishing a new standard of care in immunosuppression therapy for organ transplant patients.

Currently, Eledon is conducting the Phase 2 BESTOW trial (NCT05983770), the Phase 1b trial (NCT05027906), and a long-term safety and efficacy extension study (NCT06126380) to further evaluate tegoprubart's effectiveness in preventing organ rejection in kidney transplant patients.

Eledon Pharmaceuticals, based in Irvine, California, is a clinical-stage biotechnology company focused on developing immune-modulating therapies for treating life-threatening conditions. Tegoprubart, their lead investigational product, is an anti-CD40L antibody targeting the CD40 Ligand, a well-validated biological target with broad therapeutic potential. The central role of CD40L signaling in immune cell activation and function makes it an attractive target for non-lymphocyte depleting, immunomodulatory therapies. Eledon leverages extensive historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS).

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