Setanaxib

The European Commission approves Ipsen's IQIRVO (elafibranor) for primary biliary cholangitis, the first new therapy in the EU in a decade. Other companies, including CymaBay, Zydus, and GlaxoSmithKline, are preparing to enter the market. The approval is based on the Phase III ELATIVE trial, showing a 47% clinical benefit of IQIRVO combined with UDCA. Additionally, Gilead Sciences' LIVDELZI (seladelpar) received FDA accelerated approval for PBC.

NOX inhibitors, including Calliditas Therapeutics' setanaxib, show potential in treating fibrotic diseases and cancers by reducing ROS levels, thereby allowing CD8+ T-cells to penetrate tumors and enhance immune response. Setanaxib has shown promising results in Phase II trials for squamous cell carcinoma of the head and neck, with plans for further trials in primary biliary cholangitis and Alport Syndrome.