An experimental immunosuppressant drug being developed by Eledon Pharmaceuticals proved superior to the current standard treatment, according to data from a clinical trial, and looks to be a potential game-changer for kidney transplant patients.
Kidney recipients must take immunosuppressive drugs for their lifetime to prevent organ rejection. The medications can affect both long-term graft survival and how patients feel and function in their daily lives.
While the current standard-of-care immunosuppressant – tacrolimus, in use since the 1990s – basically affects the entire immune system, the Eledon drug, tegoprubart, selectively blocks the activation of specific immune cells in the so-called CD40L pathway.
In a long-term follow-up study of kidney transplant patients who participated in a 12-month mid-stage trial, those treated with tegoprubart had superior kidney function from one month onward compared with patients treated with tacrolimus, researchers reported at the American Transplant Congress in Boston.
Patients treated with tegoprubart had no graft loss and no biopsy-proven acute rejection episodes after the first six months post-transplant, compared with roughly 64% in the tacrolimus group.
Side effects were less common with tegoprubart as well. Just 2% of those who got the Eledon drug experienced headache or acute kidney injury versus 12% and 6% for tacrolimus, respectively. None of the patients taking the new drug had extremity pain, or falls or loss of balance, compared with 10% and 6% for the standard of care.
“For kidney transplant recipients, success is measured not only by preventing rejection, but by preserving kidney function and maintaining quality of life over the long term,” study leader Dr. Andrew Adams of the University of Minnesota said in a statement.
Eledon has said it plans to conduct a late-stage trial of tegoprubart in kidney recipients later this year.
In a separate presentation at the meeting, Dr. Nicole Wojcik from the University of Chicago reported on a pilot study in which tegoprubart was well-tolerated and effective in patients with diabetes undergoing pancreatic islet cell transplantation.