Genkyotex SA announced the enrollment of the first patient in the investigator-initiated Phase 2 clinical trial of setanaxib, the Company’s lead product candidate, in idiopathic pulmonary fibrosis (IPF). This study is conducted in accordance with the protocol approved by the U.S. Food and Drug Administration (FDA) and relevant Institutional review board (IRB). The study is being led by Professor Victor Thannickal of the University of Alabama at Birmingham and includes a consortium of five research centers of excellence in the United States. It is fully funded by an $8.9 million grant awarded to Professor Thannickal’s teams by the U.S. National Institutes of Health (NIH). The aim of the study is to evaluate the safety and efficacy of setanaxib in 60 IPF patients receiving standard treatment (pirfenidone or nintedanib) over a period of 24 weeks. The dose of setanaxib utilized will be 800 mg/day (400 mg BID), which was shown to achieve superior efficacy and a similarly favorable safety profile compared to 400 mg OD during the Phase 2 trial of setanaxib in primary biliary cholangitis (PBC). Efficacy endpoints include changes in plasma o,o'-dityrosine, a biomarker based on the mechanism of action of setanaxib, as well as standard clinical outcomes that include the 6-minute walk test and forced vital capacity (FVC). Plasma levels of collagen fragments, which could indicate anti-fibrotic activity, and the safety and tolerability of setanaxib will also be evaluated.