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Rozibafusp alfa is a first-in-class bispecific antibody–peptide fusion biologic designed to inhibit both B-cell activating factor (BAFF) and inducible T-cell costimulator ligand (ICOSL). By simultaneously blocking BAFF and ICOSL, rozibafusp alfa inhibits B-cell maturation, T-cell activation, and the aberrant communication between these cell types that drives autoimmune diseases. The molecule consists of an anti-ICOSL IgG2 antibody fused with two BAFF-binding peptides. Rozibafusp alfa has demonstrated superior efficacy compared to single-target inhibition in preclinical models of arthritis and lupus. It is being developed primarily for systemic lupus erythematosus (SLE) and has also been studied in rheumatoid arthritis (RA). Clinical trials have shown acceptable safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and patients with RA[1][2][3][4][5][6][7].
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