Eledon Pharmaceuticals has announced the completion of enrollment in its Phase 2 BESTOW clinical trial, evaluating the safety and efficacy of tegoprubart for preventing organ rejection in kidney transplant patients. The trial reached its target of 120 participants four months ahead of the original schedule.
Accelerated Enrollment Reflects Strong Interest
According to David-Alexandre C. Gros, M.D., CEO of Eledon, the rapid enrollment indicates significant interest from clinicians and patients in innovative therapies that could improve kidney transplantation outcomes compared to current standard-of-care immunosuppression regimens. The company anticipates reporting top-line results in the fourth quarter of 2025.
BESTOW Trial Design and Objectives
The BESTOW trial is a multicenter, two-arm, active comparator study conducted across North America, Europe, and Latin America. It compares tegoprubart, an anti-CD40 ligand antibody, to the calcineurin inhibitor tacrolimus. The primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR). Improved eGFR has been linked to better long-term graft survival.
Tegoprubart: A Potential Alternative to Calcineurin Inhibitors
The BESTOW trial builds on Phase 1b trial results presented at the American Transplant Congress (ATC) in June 2024. These results suggest tegoprubart could offer a safer, more effective alternative to calcineurin inhibitors, which are often associated with side effects like hyperglycemia, new-onset diabetes, hypertension, and tremors. Eledon aims to establish tegoprubart as a new standard of care in immunosuppression for organ transplant patients.
Ongoing Clinical Program
Eledon is also conducting a Phase 1b trial (NCT05027906) and a long-term safety and efficacy extension study (NCT06126380) to further evaluate tegoprubart for preventing organ rejection in kidney transplant recipients. The BESTOW trial is registered under NCT05983770.
