Eledon’s Tegoprubart Shows Sustained Kidney Function Advantage Over Tacrolimus in Long-Term Data — Eledon Pharmaceuticals, Inc.

Event summary

Eledon presented long-term Phase 2 BESTOW trial data at the American Transplant Congress, showing tegoprubart-treated patients maintained higher mean eGFR (74 vs. 61 mL/min/1.73 m²) at month 18 compared to tacrolimus.
No biopsy-proven acute rejection events were observed in tegoprubart-treated patients after six months post-transplant, while seven such events occurred in the tacrolimus arm.
Patient-reported outcomes favored tegoprubart with statistically significant improvements on validated measures of symptom burden at 52 weeks.
Eledon plans to initiate Phase 3 clinical development of tegoprubart for kidney transplantation in late 2026.

The big picture

Eledon’s data reinforces the potential of tegoprubart to challenge tacrolimus, the current standard of care for kidney transplant immunosuppression. The sustained kidney function and rejection-free outcomes could address a critical unmet need in transplant medicine, particularly as lifelong immunosuppression impacts graft survival and patient quality of life.

What we're watching

Regulatory Pathway: Whether the FDA’s End-of-Phase 2 meeting framework will streamline tegoprubart’s Phase 3 development and approval process.
Clinical Execution: The pace at which Eledon can enroll patients in its planned Phase 3 trial, given the complexity of transplant studies.
Market Differentiation: How sustained kidney function and improved patient-reported outcomes will position tegoprubart against tacrolimus in the long-term immunosuppression market.