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Eledon Announces Positive Topline Results from Phase 2a Trial of Tegoprubart Demonstrating Safety, Target Engagement, and Biomarker Response in Patients Living with Amyotrophic Lateral Sclerosis
Tegoprubart was well-tolerated, with no drug-related serious adverse eventsDose dependent target engagement was demonstrated, and ALS associated
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"Tegoprubart was well-tolerated, with no drug-related serious adverse eventsDose dependent target engagement was demonstrated, and ALS associated pro-inflammatory biomarkers were both observed and significantly reduced in a dose dependent mannerTarget engagement and level of pro-inflammatory biomarker reduction were associated with a trend in the slowing of disease progression as measured by ALSFRS slope when compared to a cohort from the ALS PRO-ACT databaseBiomarkers significantly reduced included biomarkers also associated with IgA nephropathy and kidney allograft transplant rejectionEledon management will host a webcast and conference call regarding these clinical results at 8:00 a.m. ET today, May 31, 2022 IRVINE, Calif., May 31, 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 announced topline results from a Phase 2a clinical trial of tegoprubart (formerly AT-1501) in patients with amyotrophic lateral sclerosis (ALS).1 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 ...