Eledon Pharmaceuticals, Inc., A Patient-Focused Clinical Stage Biopharmaceutical Company, Announced Topline Results From A Phase 2A Clinical Trial Of Tegoprubart (Formerly At-1501) In Patients With Amyotrophic Lateral Sclerosis (Als).Tegoprubart Is An Investigational Humanized Monoclonal Antibody That Inhibits Cd40 Ligand (Cd40L), A Membrane Protein Linked To Increased Peripheral Immune Responses And Neuroinflammation In Als. The 12-Week Trial Included 54 Patients With Als At 13 Treatment Sites In The United States And Canada. The Primary Objectives Of The Study Were To Assess The Safety And Tolerability Of Multiple Doses Of Tegoprubart In Four Sequential, Ascending Dose Cohorts (1, 2, 4, And 8 Mg/Kg). Secondary Outcome Measures Included Pharmacokinetic Assessment Of Multiple Intravenous Doses Of Tegoprubart On Target Engagement And On Pro-Inflammatory Biomarkers Associated With Als. Each Subject Served As Their Own Control, With Changes Being Compared To Baseline.Tegoprubart Successfully Met The Primary Endpoints Of Safety And Tolerability. Adverse Events Were Equally Distributed Across Dose Levels. Tegoprubart Was Well-Tolerated, And No Drug-Related Serious Adverse Events Were Observed. Anti-Drug Antibodies (Adas) Were Present In Less Than 5 Percent Of Samples. All Adas Were Of Low Titer And Did Not Impact Tegoprubart Drug Levels.Tegoprubart Target Engagement Was Demonstrated At The 4 And 8 Mg / Kg Dosing Levels Using Cd40L And Cxcl13 Biomarkers Related To T Cell And B Cell Function, Respectively. A Pro-Inflammatory Als Signature Was Identified, Consisting Of 32 Different Inflammatory Biomarkers In The Tested Population, Including Tnf-A, Mcp1, En-Rage, C-Reactive Protein (Crp), And Il-6. Il-1 Was Not Significantly Detected In The Study Patient Population. Dose Dependent, Significant Reductions Were Observed In Up To 23 Of These Biomarkers, Including Tnf-A, Mcp1, En-Rage, And Crp. Other Pro-Inflammatory Biomarkers Significantly Reduced Included Biomarkers Also Associated With Iga Nephropathy And Kidney Transplant Rejection, Such As Iga, Ige, Igm, C3, Cxcl9, And Cxcl10. While The Study Was Neither Primarily Designed Nor Powered To Assess The Effect Of Tegoprubart On Als Functional Rating Scale (
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