Eledon tegoprubart shows promise in kidney transplant patients in phase 1b trial
Sean Anthony Eddy
Eledon Pharmaceuticals (NASDAQ:ELDN) reported data from an ongoing phase 1b trial of tegoprubart in patients undergoing kidney transplant and safety data from a phase 2a trial of tegoprubart in IgA Nephropathy (IgAN).
The company presented data from the two studies at the World Congress of Nephrology.
Phase 1b trial:
The trial is enrolling up to 12 people and is evaluating tegoprubart as a novel component of an immunosuppressive regimen in kidney transplant patients.
Participants receive rabbit antithymocyte globulin (ATG) induction and a maintenance regimen comprising of tegoprubart 20 mg/kg IV (given every 3 weeks after an initial loading regimen), mycophenolate mofetil and corticosteroids.
Eledon said data from three people showed no incidence of acute rejection at durations of 56, 154, and 232 days.
The three people had estimated glomerular filtration rate (eGFRs) of 54, 85, and 77 at 49 days, 154 days, and 217 days, respectively.
EGFRs is a measure of how well the kidneys are working.
The company said one person was discontinued from the study on day 55 after developing BK viremia — a viral infection which sometimes occur in kidney transplant patients.
A second person elected to discontinue the study after 33 weeks for reasons not due to tegoprubart or related to kidney function, the company added.
"Now, we are demonstrating how tegoprubart’s broad anti-inflammatory effect results in a clinical benefit in the prevention of rejection and the protection of kidneys after transplantation," said CEO David-Alexandre Gros.
Phase 2a trial:
Eledon said data from 16 people showed that tegoprubart was safe and well tolerated in people with IgAN, and there were no serious or severe adverse events.
IgA Nephropathy — a disease which occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This leads to inflammation which can hamper the kidneys' ability to filter waste from the blood.