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Eledon Announces Completion of Enrollment in Phase 2 BESTOW Clinical Trial Assessing Tegoprubart for Prevention of Organ Rejection in Kidney Transplant Patients
Enrollment Completed Four Months Ahead of Schedule IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN)
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"Enrollment Completed Four Months Ahead of Schedule\nIRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has successfully completed enrollment for its Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of its investigational immunosuppression therapy tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target enrollment of 120 participants approximately four months earlier than originally planned. “We are very pleased to achieve this critical milestone ahead of schedule in our BESTOW trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The accelerated pace of enrollment reflects the strong interest among both clinicians and patients in new innovative therapies that have the potential to improve outcomes in kidney transplantation compared to current standard of care immunosuppression regimens. We are proud to be leading the effort to transform the prevention of organ rejection and based on the early completion of enrollment, we now anticipate reporting top-line results for the BESTOW trial in the fourth quarter of 2025.” BESTOW, a multicenter, two-arm, active comparator clinical study, enrolled 120 participants undergoing kidney transplantation at sites in North America, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart, an anti-CD40 ligand antibody, compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Research has shown that better graft function as assessed by eGFR has been associated with improved long-term graft survival following kidney transplantation. “Completing enrollment in the Phase 2 BESTOW trial is a significant achievement for our team and, more importantly, for the transplant community,” said Steve Perrin, Ph.D., Chief Scientific Officer and President of Eledon. “It is a testament to the strong collaboration with our clinical sites and the enthusiasm within the community for advances in immunosuppression therapy, an area of research that has not seen major therapeuti...