Eledon Pharmaceuticals begins dosing in Phase 2 trial of tegoprubart

Eledon Pharmaceuticals announced the first participant has been dosed in the company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. BESTOW will enroll approximately 120 participants undergoing kidney transplantation in the U.S. and other countries 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, in participants treated with tegoprubart compared to tacrolimus. Better graft function has been associated with improved long-term patient and graft survival. Secondary objectives will include graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant. Eledon previously reported results from the first three participants dosed in the company’s ongoing Phase 1b trial. Results showed no incidence of acute rejection and strong graft function observed in all three participants, with mean eGFRs above historical averages with standard of care at measured timepoints out to 31 weeks. The trial currently has enrolled 11 participants to date and will continue in parallel with the Phase 2 BESTOW trial.