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Edratide is a synthetic 19-amino acid peptide based on the complementarity-determining region 1 (CDR1) of a human anti-DNA monoclonal antibody bearing the 16/6 idiotype, which is clinically relevant in systemic lupus erythematosus (SLE). Developed by Teva Pharmaceutical Industries, Edratide acts as an immunomodulator. Its mechanism involves binding to major histocompatibility complex class II molecules and inducing regulatory T cells, leading to downregulation of autoreactive T and B cells associated with SLE. Preclinical and clinical studies have shown that Edratide can reduce gene expression of pathogenic cytokines, apoptosis-related genes, and BLyS while upregulating immunosuppressive molecules such as TGF-beta. In phase II trials for SLE, Edratide was safe and well tolerated but did not meet primary efficacy endpoints; however, it showed promising effects in certain secondary endpoints[2][3][7].
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