ASP5094 + methotrexate

ASP5094 + methotrexate is a combination investigational therapy studied for the treatment of moderate to severe rheumatoid arthritis, particularly in patients with inadequate response to methotrexate alone. ASP5094 is a humanized monoclonal antibody targeting integrin alpha-9, designed to inhibit the activation of fibroblast-like synoviocytes overexpressing integrin alpha-9, a mechanism implicated in rheumatoid arthritis pathogenesis. Methotrexate is a well-established disease-modifying antirheumatic drug (DMARD) that inhibits dihydrofolate reductase, affecting both DNA synthesis and immune modulation. The combination was studied in a Phase 2a randomized, placebo-controlled trial (NCT03257852) with intravenous administration of ASP5094 and continued background oral methotrexate. The study did not demonstrate efficacy over placebo in terms of ACR50 response rates, but the combination was safe and well tolerated[1][3][5][7][9].