ADX-097

ADX-097 is a first-in-class, tissue-targeted complement inhibitor developed as a humanized anti-C3d monoclonal antibody fused to the first five consensus repeats of human factor H (fH 1–5). Its mechanism of action involves selectively inhibiting the alternative complement pathway in diseased tissues—such as the kidney—by binding to C3d deposits, thereby restoring local complement regulation while sparing systemic complement activity. This targeted approach aims to reduce disease-causing inflammation and injury in autoimmune and inflammatory renal diseases without increasing infection risk associated with systemic complement blockade. ADX-097 is being developed by Q32 Bio and is currently under investigation in Phase 2 clinical trials for IgA nephropathy, lupus nephritis, complement component 3 glomerulopathy, and ANCA-associated vasculitis[1][2][5][6].