Eledon tegoprubart shows 13 mL/min eGFR edge over tacrolimus
Eledon Pharmaceuticals has presented updated long-term data from the Phase 2 BESTOW extension study at the International Congress of The Transplantation Society in Sydney, showing its lead candidate tegoprubart maintained a statistically significant advantage over the standard-of-care calcineurin inhibitor tacrolimus in kidney transplant recipients through 24 months.
At the data cutoff, 81 patients had been followed through 24 months. Tegoprubart-treated patients recorded a mean estimated glomerular filtration rate of 71 mL/min/1.73 m², compared with 58 mL/min/1.73 m² in the tacrolimus arm, a difference of approximately 13 mL/min/1.73 m² that was statistically significant at months 18, 21 and 24. The eGFR gap is clinically meaningful: sustained kidney function at that level can translate to materially slower progression toward dialysis dependency over a transplant's lifetime. No cases of biopsy-proven acute rejection were recorded in the tegoprubart arm beyond six months post-transplant, against seven in the tacrolimus arm. One new graft loss was reported in the tacrolimus group.
Regulatory context
The FDA has granted tegoprubart Fast Track designation for the prevention of rejection in kidney transplantation, a status that allows more frequent agency interactions, rolling review of marketing applications, and potential eligibility for Accelerated Approval and Priority Review. Eledon said a successful End-of-Phase 2 meeting with the agency had already been completed, clearing the path for its Phase 3 LEGACY study, which the company expects to initiate in the fourth quarter of 2026.
LEGACY is designed to enrol approximately 600 patients and will assess non-inferiority of tegoprubart versus tacrolimus on a composite endpoint of biopsy-proven acute rejection, graft loss and death at 12 months. David-Alexandre C. Gros, chief executive of Eledon, said the BESTOW extension data "strengthen our belief in tegoprubart's potential to become the new cornerstone immunosuppression therapy for kidney transplant recipients." The oral presentation at the Sydney congress was delivered by Andrew Adams, Professor of Surgery and chief of the Division of Transplantation at the University of Minnesota.
Market landscape
Tegoprubart is an anti-CD40L monoclonal antibody, a mechanistic class that has attracted renewed interest after earlier anti-CD40L compounds were discontinued due to thromboembolic side-effects linked to platelet CD40L expression. Eledon argues that its compound's engineering addresses those earlier safety concerns, though independent confirmation at Phase 3 scale will be required. The kidney transplant immunosuppression market is dominated by tacrolimus-based regimens, and the clinical burden of calcineurin inhibitor nephrotoxicity, which progressively erodes graft function over years, remains a long-recognised problem without a widely adopted alternative. A durable, well-tolerated substitute with a statistically significant eGFR advantage would be a commercially meaningful proposition for the estimated 25,000 kidney transplants performed annually in the United States alone. Several other investigational immunosuppression approaches, including co-stimulation blockade with belatacept and novel JAK inhibitors, are in development or have reached the market, meaning Eledon will need robust Phase 3 safety and efficacy data to differentiate tegoprubart in a competitive field.