Business
Eledon Pharmaceuticals Provides Corporate Update and 2022 Outlook
Completed enrollment of all four cohorts in ongoing Phase 2a study with tegoprubart (AT-1501) in Amyotrophic Lateral Sclerosis (ALS) Announces USAN Approval
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"Completed enrollment of all four cohorts in ongoing Phase 2a study with tegoprubart (AT-1501) in Amyotrophic Lateral Sclerosis (ALS) Announces USAN Approval of Generic Name “tegoprubart” for lead asset AT-1501 Catalyst-rich period ahead with four clinical trial readouts anticipated in 2022 Well capitalized with sufficient cash to fund operations into 2024 IRVINE, Calif., Feb. 14, 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 provided a summary of key 2021 accomplishments and previewed anticipated 2022 milestones. 2021 Key Highlights Completed enrollment of all four cohorts in ongoing Phase 2a study with tegoprubart in Amyotrophic Lateral Sclerosis (ALS).Received regulatory clearance to initiate a Phase 1b clinical trial in Canada and the United Kingdom, evaluating tegoprubart as a replacement for tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation.Received regulatory clearance to initiate a Phase 2a clinical trial in Australia and New Zealand, evaluating tegoprubart for the treatment of IgA Nephropathy, with plans to expand the study in up to nine additional countries in 2022.Obtained FDA clearance to initiate a Phase 2a U.S. clinical trial in islet cell transplantation utilizing tegoprubart to prevent allograft rejection for the treatment of Type 1 diabetes.Presented pre-clinical data demonstrating the effectiveness of tegoprubart in preventing islet cell allograft rejection resulting in improved metabolic control in a nonhuman primate model of diabetes.United States Adopted Names (USAN) Council adopted “tegoprubart” as the unique non-proprietary or generic name for AT-1501. Going forward, Eledon will use tegoprubart in place of AT-1501.Announced a collaborative research agreement to incorporate CareDx’s biomarker and predictive algorithm technologies into Eledon’s clinical trials of tegoprubart in renal transplantation. “2021 was a year of execution and expansion of our clinical development program, as we advanced our ALS study and received global regulatory clearances to initiate trials in multiple other indications. We enter ...