Abstract: TH-OR089
Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial
Session Information
- Late-Breaking Research Orals - 1
November 06, 2025 | Location: Grand Ballroom C, Convention Center
Abstract Time: 05:30 PM - 05:42 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Adams, Andrew B., University of Minnesota Medical School, Minneapolis, Minnesota, United States
- Tedesco-Silva, Helio, Universidade Federal de Sao Paulo Hospital do Rim e Hipertensao, São Paulo, SP, Brazil
- Potter, Steven, MedStar Georgetown University Hospital, Washington, District of Columbia, United States
- Laurito, Marcela, Eledon Pharmaceuticals, Irvine, California, United States
- Hovland, David, Eledon Pharmaceuticals, Irvine, California, United States
- Crespo, Marta, Hospital del Mar, Barcelona, Spain
- Woodle, E. Steve, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States
- Bestard, Oriol, Vall d'Hebron Institut de Recerca, Barcelona, CT, Spain
- Li, Yulan, Eledon Pharmaceuticals, Irvine, California, United States
- Thomas, Elizabeth, Eledon Pharmaceuticals, Irvine, California, United States
- Kamar, Nassim, Centre Hospitalier Universitaire de Toulouse, Toulouse, Occitanie, France
- Perrin, Steven, Eledon Pharmaceuticals, Irvine, California, United States
- Demetris, Anthony J., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
- Katz, Eliezer, Eledon Pharmaceuticals, Irvine, California, United States
- Vincenti, Flavio, University of California San Francisco, San Francisco, California, United States
Background
Calcineurin inhibitors like tacrolimus help prevent acute graft rejection in the first year following kidney transplantation. However, long-term use is associated with adverse effects, including nephrotoxicity, new-onset diabetes mellitus after transplantation (NODAT), and neurotoxicity. Tegoprubart, a monoclonal antibody, targets the CD40 ligand to inhibit costimulatory immune pathways and suppress the immune response. Phase 1 data demonstrated preliminary efficacy and an acceptable safety profile. We will report Phase 2 efficacy and safety data on tegoprubart vs tacrolimus in preserving allograft function after de novo kidney transplantation.
Methods
BESTOW (NCT05983770) is a Phase 2, multicenter, randomized, open-label, active controlled trial in adults receiving their first kidney transplant from a living or deceased donor; enrollment target was 120 patients. All received rabbit anti-thymocyte globulin as induction, corticosteroids, and mycophenolate. Patients were randomized 1:1 to intravenous tegoprubart 20 mg/kg on days 1, 3, 7, 14, 21, 28, and every 21 days thereafter, or twice daily oral tacrolimus at a target whole blood trough concentration of 6–12 ng/mL to month 6, and 6–8 ng/mL thereafter. Primary endpoint is graft function at month 12, assessed by estimated glomerular filtration rate (2021 chronic kidney disease epidemiology formula using serum creatinine). Key secondary endpoints at month 12 include rates of efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death), with sensitivity analyses including rejection rate from both BPAR and required biopsies not performed (protocol deviation); graft functional impairment; tremor; hypertension; and hyperglycemia/NODAT. Safety endpoints include incidence of treatment-emergent adverse events.
Results
A total of 127 participants were enrolled in the BESTOW study, with study data due by October 31, 2025. Initial efficacy and safety results at 12 months will be presented.
Conclusion
The results of the BESTOW study may provide a basis for continuing the development of tegoprubart as a potential alternative to tacrolimus for preserving allograft function and preventing kidney transplant rejection.
Funding
- Commercial Support – Eledon Pharmaceuticals, Inc.