Eledon Pharmaceuticals has dosed the first participant in the Phase II BESTOW trial of tegoprubart to prevent organ rejection during kidney transplantation.
The active comparator, two-arm, multicentre study is designed to assess the pharmacokinetics, efficacy, and safety of the anti-CD40 ligand antibody tegoprubart against the calcineurin inhibitor tacrolimus.
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It intends to enrol around 120 participants undergoing kidney transplantation in the US and other countries.
The primary aim of the study is to evaluate graft function at 12 months after transplant, as measured by estimated glomerular filtration rate (eGFR).
Secondary objectives include biopsy-proven acute rejection, graft survival, and the incidence of new onset diabetes mellitus after transplant.
The study will also assess clinical, histological, and serum biomarkers using the iBox Scoring System for the early prediction of graft failure, as an exploratory endpoint.
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By GlobalDataEledon CEO David-Alexandre Gros said: “This study aims to build on the growing body of evidence, including recently reported results from our Phase Ib trial, reinforcing our belief in the potential of tegoprubart to replace calcineurin inhibitors and provide kidney transplant recipients a much-needed alternative associated with better kidney function, reduced side effects and longer lifespans for transplanted organs.
“We look forward to generating further insights into the therapeutic potential of tegoprubart in comparison to the standard of care, while continuing to run our Phase Ib in parallel, positioning us to report multiple data updates over the next 18 months.”
In a Phase Ib trial, no incidence of acute rejection and strong graft function were observed in all three participants who received tegoprubart for 31 weeks. This trial enrolled 11 participants till date.
