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CIGB-814 is an altered peptide ligand (APL) designed for the treatment of rheumatoid arthritis. It is a synthetic peptide derived from the 83-109 amino acid sequence of human heat-shock protein 60 (HSP60), featuring a specific mutation (D100→L) that increases its affinity for HLA-II molecules associated with the disease. Developed by the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba, with clinical sponsorship from Yi Fang, CIGB-814 acts by modulating the adaptive immune response and inducing peripheral tolerance. Preclinical and early clinical studies indicate that the drug can reduce anti-citrullinated protein antibodies (anti-CCP) and decrease disease activity scores. It is administered via subcutaneous injection and has been evaluated in Phase I trials for safety, pharmacokinetics, and pharmacodynamics in both healthy volunteers and patients with rheumatoid arthritis.
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