Eledon Pharmaceuticals Receives FDA Clearance of IND Application to Evaluate Tegoprubart for the Prevention of Rejection in Kidney Transplant Recipients

August 1, 2022

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 Executive Officer of Eledon. "We look forward to launching this trial and to the initial data from our ongoing kidney transplantation study in Canada, the UK and Australia."

About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40 Ligand (CD40L, also called CD154) pathway to develop potential treatments for persons requiring an organ or cell-based transplant, living with autoimmune disease, or living with ALS. The company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.

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Source: Eledon Pharmaceuticals, Inc.