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Eledon Reports Data from Ongoing Phase 1b Trial Evaluating Tegoprubart in Patients Undergoing Kidney Transplantation at World Congress of Nephrology
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
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"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 immunosu...