Eledon's Tegoprubart Shows Promise in Phase 2 Kidney Transplant Trial, Advances to Phase 3 Development
Key Insights
Eledon Pharmaceuticals' Phase 2 BESTOW trial demonstrated tegoprubart's favorable safety profile in kidney transplantation (search), reducing metabolic, neurologic, and cardiovascular toxicities associated with standard tacrolimus therapy.
The anti-CD40L (search) antibody achieved a mean eGFR of 69 mL/min/1.73 m² at 12 months, which the company believes is the highest reported in larger kidney transplant rejection prevention trials.
All six type 1 diabetes (search) patients treated with tegoprubart following islet transplantation achieved insulin independence, with the first three remaining insulin-free for over one year.
Eledon Pharmaceuticals reported encouraging results from its Phase 2 BESTOW clinical trial evaluating tegoprubart, an anti-CD40L (search) antibody, for preventing organ rejection (search) in kidney transplant patients. The data, presented at the American Society of Nephrology's Kidney Week 2025 Annual Meeting, support the advancement of tegoprubart into Phase 3 development as a potential safer alternative to current immunosuppression therapy.
Phase 2 BESTOW Trial Results
The Phase 2 BESTOW trial demonstrated tegoprubart's favorable safety and tolerability profile, significantly reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus, the current standard of care in immunosuppression therapy. Study participants treated with tegoprubart achieved a mean estimated glomerular filtration rate (eGFR) of 69 mL/min/1.73 m² (n=51) at 12 months, which Eledon believes represents the highest mean eGFR level reported to date in larger kidney transplant clinical trials evaluating rejection prevention.
The efficacy failure composite endpoint, including rejection rate, was 22.2% in the tegoprubart group compared to 17.2% in the tacrolimus group, demonstrating non-inferiority for tegoprubart versus tacrolimus using a 20% non-inferiority margin.
"We were particularly encouraged by results from our Phase 2 BESTOW trial, presented at ASN Kidney Week in November, which further validated the favorable safety and tolerability profile of tegoprubart," said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon.
Breakthrough Results in Type 1 Diabetes
Eledon also reported positive preliminary results from the first six patients with type 1 diabetes (search) treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine (search)'s Transplant Institute. All six treated patients achieved insulin independence with marked improvements in glycemic control after one or two transplants, with the first three remaining insulin-free for more than one year after transplant.
The results demonstrated prevention of islet rejection without calcineurin inhibitors (CNIs), such as tacrolimus, and sustained insulin-free HbA1c control. To date, a total of eight patients have undergone islet transplantation with tegoprubart as the core immunosuppressant, and one additional patient with CNI-associated nephrotoxicity was transitioned to tegoprubart from tacrolimus.
Xenotransplantation Applications
Tegoprubart continues to serve as a key component of immunosuppression regimens in xenotransplants. The drug was used as a cornerstone component of the immunosuppression treatment regimen in a patient who received a xenotransplant of a genetically modified pig kidney, conducted at Massachusetts General Hospital in collaboration with eGenesis (search). This procedure marked the fourth use of tegoprubart in a pig-to-human xenotransplant and the third use at MGH.
Financial Position and 2026 Outlook
Eledon completed a $57.5 million underwritten public offering of common stock and pre-funded warrants, which is anticipated to support company operations into the second quarter of 2027. The company has outlined several key milestones for 2026, including receiving FDA guidance on Phase 3 trial design for kidney transplantation (search) and initiating the Phase 3 trial pending regulatory alignment.
Additional 2026 milestones include reporting long-term data from Phase 1 and Phase 2 BESTOW studies, presenting updated data from type 1 diabetes (search) patients in the islet cell transplantation study, and receiving FDA regulatory guidance on the path to market for tegoprubart in islet cell transplantation and xenotransplantation.
About Tegoprubart
Tegoprubart is an anti-CD40L (search) antibody with high affinity for the CD40 Ligand, a well-validated biological target with broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. Eledon is building upon deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, and amyotrophic lateral sclerosis.