Eledon Pharmaceuticals (NASDAQ:ELDN) announced that the first patient in a phase 1b trial of tegoprubart in kidney transplant patients has been dosed. In the trial, which has been approved in Canada and the United Kingdom, up to 12 patients undergoing kidney transplantation will take tegoprubart in combination with rabbit anti-thymocyte globulin (rATG) induction, and mycophenolate mofetil and an oral steroid taper for maintenance therapy. The trial will assess the safety, pharmacokinetics, and efficacy of tegoprubart, as well as the incidence of biopsy-proven acute rejection, immune cell infiltration of graft biopsy, and biomarker assessments of kidney injury and rejection risk.
In the United States, more than 20,000 people have a kidney transplant each year, and another 90,000 people will wait an average of three to five years for a transplant. Re-transplants account for up to 15 percent of annual transplant surgeries; therefore, reducing the necessity for re-transplantation would increase the organ supply for new patients. In addition, tegoprubart aims to address the difficulties associated with current immunosuppressive calcineurin inhibitor (CNI)-based regimens, which are associated with up to a 30% incidence of new-onset diabetes post-transplant, as well as hypertension, kidney-toxicity, and neurotoxicity.
Eledon CEO David-Alexandre Gros said that we think that tegoprubart has the potential to revolutionize the clinical management of kidney transplantation by preventing graft rejection, minimizing the various toxicities associated with CNIs, and ultimately enhancing long-term results.
The U.S. Food and Medication Administration designated tegoprubart as an orphan drug in June for the prevention of allograft rejection in pancreatic islet cell transplantation.
Concerning Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)
Eledon Pharmaceuticals is a clinical-stage biotechnology company that utilizes its expertise in targeting the CD40 Ligand (CD40L, also known as CD154) pathway to develop potential treatments for individuals requiring an organ or cell-based transplant, living with an autoimmune disease, or living with amyotrophic lateral sclerosis (ALS).
The company’s principal development chemical is tegoprubart, an anti-CD40L antibody with a high affinity for CD40 Ligand, a confirmed biological target with significant therapeutic potential. Eledon is based in Irvine, California.
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