Exploratory biomarkers including donor derived cell free DNA, and the incidence of biopsy proven rejection are some of the other endpoints of the trial. Credit: CDC on Unsplash.

At the World Congress of Nephrology, Eledon Pharmaceuticals reported data from its ongoing Phase Ib trial of tegoprubart in individuals undergoing kidney transplantation.

Up to 12 participants who are undergoing kidney transplants in the UK, Australia, and Canada are currently being enrolled in the trial.

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In the trial, each patient receives rabbit antithymocyte globulin (ATG) induction along with a maintenance regimen comprising tegoprubart 20mg/kg IV (given every three weeks following an initial loading regimen), mycophenolate mofetil, and corticosteroids.

Safety is the trial’s primary endpoint.

Changes in estimated glomerular filtration rate (eGFR), characterising the pharmacokinetic profile of tegoprubart, exploratory biomarkers including donor derived cell free DNA, and the incidence of biopsy proven rejection are some of the other endpoints of the trial.

Findings from the first three study participants showed no incidence of acute rejection at 56, 154, and 232 days.

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They had 54, 85, and 77 eGFRs at the latest available timepoint of 49, 154, and 217 days, respectively.

On day 55, a participant discontinued from the study after developing BK viremia, which is a common occurrence following kidney transplant.

After 33 weeks, a second participant chose to discontinue the study for reasons not attributed to tegoprubart or related to kidney function.

All the three participants had strong graft function with mean eGFRs above 70 mL/min/1.73m2 at measured timepoints.

Additionally, the company has reported data from its Phase IIa trial of tegoprubart in IgA Nephropathy (IgAN).

Tegoprubart was found to be safe and well tolerated and there were no serious or severe adverse events reported in the Phase II trial.

Eledon Pharmaceuticals CEO David-Alexandre Gros said: “We are highly encouraged by the results to date from our ongoing Phase Ib trial evaluating tegoprubart as a novel component of an immunosuppressive regimen in kidney transplant patients.

“Previously in our Phase II ALS trial, we reported dose dependent target engagement and how that target engagement resulted in a broad, dose dependent decrease in proinflammatory biomarkers.

“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.”