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BT063 is a humanized monoclonal antibody designed to neutralize interleukin-10 (IL-10). Developed by Biotest (and later sponsored by Grifols), the drug was primarily investigated for the treatment of systemic lupus erythematosus (SLE). While IL-10 is generally considered an anti-inflammatory cytokine, in the context of SLE, it is often overexpressed and contributes to disease pathogenesis by promoting B-cell differentiation and the production of autoantibodies. BT063 was evaluated in a Phase IIa proof-of-concept study (NCT02554019) to assess its safety and efficacy in patients with moderate to severe SLE. However, following the completion of this study in 2018, no further clinical trials have been initiated, and the program is considered discontinued.
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