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Anselamimab is a humanized IgG1κ monoclonal antibody developed for the treatment of amyloid light-chain (AL) amyloidosis, a rare and serious condition characterized by the deposition of amyloid fibrils in organs such as the heart. It functions by specifically binding to amyloid fibrils, particularly targeting serum amyloid A1 (SAA1), thereby triggering the phagocytic removal of amyloid deposits by macrophages and neutrophils. Its mechanism involves inhibition of serum amyloid A protein as well as the physical clearance of fibril deposits. Clinical trials have primarily evaluated its efficacy in patients with advanced cardiac AL amyloidosis (notably stage IIIa and IIIb), with endpoints focusing on survival, cardiac function, and quality of life. Anselamimab has received orphan drug designations and has been investigated in large international Phase 3 trials. Although it did not meet the primary endpoint of improved survival in its main Phase 3 study, it showed clinical benefit in a prespecified subgroup and remains notable as a first-in-class investigational fibril-depleting agent for AL amyloidosis[2][3][5][6][8].
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