Eledon Pharmaceuticals, Inc. (Eledon), a clinical stage biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Tegoprubart has previously received orphan drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS).
“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.”
Orphan Drug Designation is intended to support the development of therapies for rare diseases, defined as conditions affecting fewer than 200,000 people in the United States or fewer than 5 in 10,000 individuals in the European Union. These designations provide sponsors with a range of incentives intended to encourage the development of medicines for diseases with high unmet medical needs.
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signalling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). |