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Eledon Pharmaceuticals Receives FDA Clearance of IND Application to Evaluate Tegoprubart for the Prevention of Rejection in Kidney Transplant Recipients
IRVINE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"IRVINE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. The IND-opening phase 2 study will be a multicenter, open-label, 2-arm, active comparator safety, pharmacokinetic, and efficacy study that will enroll approximately 120 participants (60/arm) undergoing kidney transplant. Participants will receive tegoprubart or the active comparator, tacrolimus, as part of an immunosuppressive regimen including corticosteroids and mycophenolate mofetil (MMF) or mycophenolate sodium (MPS). The study’s primary objective is to assess superiority of graft function at 12 months post-transplant in tegoprubart-treated participants compared with tacrolimus-treated participants. The primary endpoint will compare the mean estimated glomerular filtration rate (eGFR) at 12 months for tegoprubart vs. current standard of care. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival. Secondary objectives include safety, incidence of new onset diabetes, and participant and graft survival. More than 23,000 people undergo a kidney transplant in the United States every year. Nationwide, only about a quarter of persons on the transplant waitlist will receive a deceased donor kidney transplant within 5 years, in part because approximately 10% of yearly kidney transplants are re-transplants. Tegoprubart seeks to reduce drug-associated morbidity and improve graft survival associated with current standard of care regimens including calcineurin inhibitors (CNIs). \"We believe strongly in tegoprubart’s potential to supplant CNIs in the immunosuppressive regimen of kidney transplant patients, potentially leading to reduced side effects such as diabetes and hypertension, better kidney allograft function, and a resulting longer functional life of transplanted kidneys,\" said David-Alexandre C. Gros, MD, Chief Executi...