Results from three participants demonstrated no incidence of acute rejection at durations of 56, 154, and 232 days
Strong graft function observed in all three participants with mean eGFRs above 70 mL/min/1.73m2 at measured timepoints
Data from 16 participants in the Phase 2 IgAN study demonstrated tegoprubart to be safe and well tolerated, with no serious or severe adverse events reported
IRVINE, Calif., March 31, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart in patients undergoing kidney transplantation at the World Congress of Nephrology, which is taking place March 30 to April 2, 2023. In addition, Eledon reported safety data from the Company’s Phase 2a trial of tegoprubart in IgA Nephropathy (IgAN).
The Phase 1b open-label study is enrolling up to 12 participants undergoing kidney transplantation in Canada, Australia, and the United Kingdom. Each participant receives rabbit antithymocyte globulin (ATG) induction and a maintenance regimen consisting of tegoprubart 20 mg/kg IV (administered every 3 weeks after an initial loading regimen), mycophenolate mofetil, and corticosteroids. The primary endpoint of the study is safety. Other endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection, changes in estimated glomerular filtration rate (eGFR), and exploratory biomarkers including donor derived cell free DNA.
Results from the first three participants at the time of data submission to the conference demonstrated no incidence of acute rejection at 56, 167, and 232 days. The three participants had eGFRs of 54, 85, and 77 at the latest available timepoint of 49, 154, and 217 days, respectively. Regarding adverse events, one participant was discontinued from the study on day 55 after developing BK viremia, a common occurrence after kidney transplant that is related to immunosuppression and reported to occur in approximately 20% or more of kidney transplant patients. A second participant elected to discontinue the study after 33 weeks for reasons not attributed to tegoprubart or related to kidney function.
“We are highly encouraged by the results to date from our ongoing Phase 1b trial evaluating tegoprubart as a novel component of an immunosuppressive regimen in kidney transplant patients,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “Previously in our Phase 2 ALS trial, we reported dose dependent target engagement and how that target engagement resulted in a broad, dose dependent decrease in proinflammatory biomarkers. Now, we are demonstrating how tegoprubart’s broad anti-inflammatory effect results in a clinical benefit in the prevention of rejection and the protection of kidneys after transplantation. We look forward to completing enrollment in this kidney transplant trial and continuing to develop a much-needed treatment option that better protects an organ that many patients wait years to receive.”
Eledon also presented safety data in a poster presentation from the Company’s Phase 2a open-label study evaluating tegoprubart for the treatment of IgAN. The available data suggests that tegoprubart is safe and well tolerated in people with IgAN, with no serious or severe adverse events reported. To date, approximately 100 human subjects have been dosed with tegoprubart across multiple disease indications.
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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