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netakimab + ursodeoxycholic acid is a combination therapy being investigated for the treatment of primary biliary cholangitis (PBC). The combination consists of netakimab (BCD-085), a humanized monoclonal antibody that targets and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A), and ursodeoxycholic acid (UDCA), a naturally occurring bile acid that serves as the standard of care for PBC. The rationale for this combination is based on the role of IL-17A in the autoimmune pathogenesis of PBC, where it contributes to the destruction of bile ducts. By adding an IL-17A inhibitor to UDCA, the therapy aims to achieve a better biochemical response in patients who have a suboptimal response to UDCA monotherapy, typically defined by elevated alkaline phosphatase (ALP) levels. The combination was evaluated in a Phase 2a open-label proof-of-concept clinical trial (NCT03476993) conducted by BIOCAD.
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