Eledon Pharmaceuticals announces U.S. FDA granted ODD to tegoprubart

Eledon Pharmaceuticals (ELDN) announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug designation, ODD, to tegoprubart for the prevention of allograft rejection in liver transplantation. “Clinical studies in kidney transplantation have demonstrated that tegoprubart has the potential to improve graft survival and function while reducing the side effects associated with calcineurin inhibitors, supporting its promise as a novel immunosuppressive therapy across multiple organ transplant settings,” said David-Alexandre C. Gros, MD, Chief Executive Officer of Eledon. “Based on the encouraging preclinical evidence we have generated to date, we believe liver transplantation represents a significant incremental opportunity for tegoprubart, and we look forward to evaluating its potential in the clinical setting through an anticipated investigator sponsored trial initiating later this year.”