Eledon's Tegoprubart Wins FDA Fast Track in Kidney Transplant as Phase 2 Data Show 24-Month eGFR Advantage Over Tacrolimus
核心洞察
Eledon Pharmaceuticals reported updated Phase 2 BESTOW extension data showing tegoprubart-treated kidney transplant patients maintained significantly higher mean eGFR than tacrolimus patients through 24 months.
At month 24, tegoprubart patients had an approximately 13 mL/min/1.73 m2 eGFR advantage over tacrolimus, 71 versus 58 mL/min/1.73 m2 (95% CI: 2.6, 23.3).
No biopsy-proven acute rejection occurred in the tegoprubart arm beyond six months post-transplant, compared with seven cases in the tacrolimus arm, plus one new graft loss in the tacrolimus arm.
Eledon Pharmaceuticals reported that tegoprubart maintained a statistically significant kidney function advantage over tacrolimus through 24 months in the Phase 2 BESTOW extension study, and that the U.S. Food and Drug Administration (搜索) has granted the anti-CD40L antibody Fast Track designation for the prevention of rejection in kidney transplantation.
The updated long-term data were presented at the International Congress of The Transplantation Society, held September 20-23, 2026, in Sydney, Australia, in a session titled "Novel immunosuppression." Andrew Adams, M.D., Ph.D., professor of surgery and chief of the Division of Transplantation at the University of Minnesota and executive medical director of the Solid Organ Transplant Service Line at M Health Fairview, delivered the oral presentation.
Kidney Function Through 24 Months
As of the data cutoff in the BESTOW long-term extension study, 90 patients had been followed through 18 months and 81 patients through 24 months. Tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR), a measure of kidney graft function, at months 18, 21 and 24.
At month 24, the mean eGFR was 71 mL/min/1.73 m2 in the tegoprubart arm versus 58 mL/min/1.73 m2 in the tacrolimus arm, an advantage of approximately 13 mL/min/1.73 m2 (95% CI: 2.6, 23.3). Treatment differences at months 18, 21 and 24 were reported as p < 0.05. Data extraction date was August 31, 2026.
Rejection and Graft Loss
No cases of biopsy-proven acute rejection (BPAR) were reported in the tegoprubart arm beyond six months post-transplant, compared with seven in the tacrolimus arm. One new case of graft loss was observed in the tacrolimus arm.
"The BESTOW extension study data and continued improvements in kidney function and safety profile with tegoprubart versus standard of care tacrolimus further strengthen our belief in tegoprubart's potential to become the new cornerstone immunosuppression therapy for kidney transplant recipients," said David-Alexandre C. Gros, M.D., chief executive officer of Eledon.
Fast Track Designation and Phase 3 Plans
The FDA's Fast Track process is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address significant unmet medical needs. Companies receiving the designation may be eligible for more frequent interactions with the FDA, rolling review of future marketing applications, and eligibility for Accelerated Approval and Priority Review.
Following a successful End-of-Phase 2 meeting with the FDA, Eledon said it remains on track to initiate the global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in the fourth quarter of 2026. The trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority of tegoprubart versus tacrolimus on a composite efficacy failure endpoint at 12 months, defined as a combination of biopsy-proven acute rejection, graft loss and death.
"These long-term results, together with FDA Fast Track designation, support our plans to initiate the Phase 3 LEGACY study in kidney transplantation in the fourth quarter and advance tegoprubart as quickly as possible for transplant patients in need of better immunosuppressive options to improve long-term outcomes," Gros said.
About Tegoprubart
Tegoprubart is an anti-CD40L antibody with high affinity for CD40 Ligand, described by the company as a well-validated biological target with broad therapeutic potential. CD40L signaling plays a central role in both adaptive and innate immune cell activation and function, positioning it as a target for non-lymphocyte depleting, immunomodulatory intervention.
Eledon, headquartered in Irvine, California, is a clinical stage biotechnology company developing immune-modulating therapies for life-threatening conditions. Beyond kidney allograft transplantation, the company is conducting preclinical and clinical studies of tegoprubart in xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (搜索).