Eledon Pharmaceuticals, Inc. presented updated data from the Company?s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the poster, titled ?Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,? were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024.

As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart?s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant.

Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant. Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively.

There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death. Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.