Eledon Pharmaceuticals announces updated data from tegoprubart trial

Eledon Pharmaceuticals (ELDN) announced updated data from the company’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the oral presentation were presented at the World Transplant Congress taking place in San Francisco, California. As of the July cutoff date, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study. Updated data showed that kidney function, as assessed by estimated glomerular filtration rate, stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for patients who remained on tegoprubart. Kidney function in the intention-to-treat population was approximately 63 mL/min/1.73 m2 at 12 months. Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean estimated glomerular filtration rates of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant. In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve five-year graft survival. Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function and immunologic response parameters into a single prognostic score. Based on data collected to date, abbreviated iBox scores were -3.75 in the intention-to-treat population and -4.11 in the on-treatment population, which compare favorably to a -2.98 historical mean for calcineurin inhibitors. A difference in abbreviated iBox score of -0.40 at 12 months is considered predictive of a 4%-5% difference in 5-year graft survival suggesting that tegoprubart may have a predicted 5-year allograft survival rate of over 96%. Mean tegoprubart treatment exposure to date was 233 days. Tegoprubart continues to be well-tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes, a side effect associated with standard of care immunosuppression therapy. There were six rejection episodes, and 75% of patients who experienced a rejection had received low-dose rabbit antithymocyte globulin induction. All rejection episodes were successfully treated. Of the patients who experienced a rejection episode and completed a year in the study, three who remained on tegoprubart had a mean eGFR of approximately 73 mL/min/1.73 m2 at 12 months, indicating full recovery of kidney function, while the two patients who switched to standard of care tacrolimus had a mean eGFR of approximately 34 mL/min/1.73 m at 12 months. All 32 patients received rATG induction therapy and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids. Cohort 1 has completed enrollment and evaluated tegoprubart at a dose of 20 mg/kg with rATG induction up to 6 mg/kg. Cohort 2 is currently enrolling and is evaluating a lower tegoprubart dose of 10 mg/kg, with a required rATG dose of 4.5 mg/kg. The primary endpoint of the study is safety and pharmacokinetics. Secondary and exploratory endpoints include patient and graft survival, biopsy-proven acute rejection, kidney function as measured by estimated by eGFR, and abbreviated iBox score. Eledon is also conducting a Phase 2 trial and a long-term safety and efficacy extension study to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Topline results from the Phase 2 BESTOW trial are anticipated in November 2025.