Business
Eledon Pharmaceuticals Reports Second Quarter 2021 Operating and Financial Results
Received approval from Health Canada to initiate a clinical trial of AT-1501 in kidney transplantation; company expects to initiate trial in Q4 with initial
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"Received approval from Health Canada to initiate a clinical trial of AT-1501 in kidney transplantation; company expects to initiate trial in Q4 with initial data in late 2022 Reached agreement with the FDA to conduct a preclinical renal transplant study evaluating AT-1501 monotherapy in four non-human primates; launched academic collaboration to conduct the study with data expected mid-2022 Announces plans to develop AT-1501 as a therapy for IgA nephropathy (IgAN), the fourth potential indication for clinical development of AT-1501; company expects to initiate Phase 2 by year-end 2021 Conference call today at 4:30 PM ET IRVINE, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc., (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today reported its second quarter 2021 operating and financial results. “We have made significant progress since the announcement in April of our updated development strategy for AT-1501 in renal transplantation,” stated David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Enrollment in our ALS study is progressing well and we anticipate completing enrollment in the 4th quarter. Separately, we received a No Objection Letter from Health Canada in response to our Clinical Trial Application proposing to initiate a clinical trial evaluating AT-1501, in 6 to 12 subjects, replacing tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation. We believe that replacing tacrolimus as an agent in renal transplantation can reduce immunosuppressive side effects and improve long-term graft survival. We look forward to reporting initial clinical data from the study late next year. In addition, we plan to initiate a preclinical renal transplant study evaluating AT-1501 monotherapy in four non-human primates, as requested by the U.S. Food and Drug Administration, with data expected in mid-2022.” “In addition to our progress in ALS and renal transplant, we have selected IgA nephropathy as the fourth indication for the clinical development of AT-1501,” said Steven Perrin, Ph.D., President and Chief Scientific Officer of Eledon. “There is strong scientif...