Eledon Pharmaceuticals reported updated Phase 2 results for tegoprubart and plans to begin a Phase 3 trial later this year.
Irvine-based Eledon Pharmaceuticals says the U.S. Food and Drug Administration has granted Fast Track designation to tegoprubart, its experimental treatment designed to help prevent rejection following kidney transplantation.
The company also reported updated results from its Phase 2 BESTOW study, including higher average kidney-function measurements at 24 months among patients receiving tegoprubart compared with patients receiving tacrolimus.
Eledon said no rejection episodes were observed in the tegoprubart group beyond six months, while seven were reported in the tacrolimus group during the same period. The findings remain clinical-trial results, and tegoprubart has not been approved for general use.
The company expects to begin its approximately 600-patient Phase 3 LEGACY trial during the fourth quarter of 2026.
