Top Line Efficacy Results from Phase 2 Primary Biliary Cholangitis (PBC) Trial
• 22% reduction in liver stiffness in PBC patients with liver fibrosis compared to a 4% increase for placebo (p=0.038), supports anti-fibrotic mechanism
• Statistically significant reduction in alkaline phosphatase (ALP) for overall treatment effect (p=0.002)
• Reduction of 19% in gamma glutamyl transpeptidase (GGT) maintained over 24 weeks but not statistically significant at week 24
• Genkyotex to hold a conference call and webcast today at 1 pm CEST (in French) and at 2pm CEST (in English)
Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX) announced today top-line efficacy data for its NOX1/4 inhibitor GKT831 Phase 2 trial in primary biliary cholangitis (PBC). In a pre-defined patient population with an estimated liver fibrosis stage of F3 or higher, GKT831 achieved a 22% reduction in liver stiffness compared to a 4% increase for placebo (p=0.038). The top-line data provide a clinical proof of concept for GKT831 and highlight its potential as an anti-fibrotic therapy in the liver and other organs. Further analyses are ongoing and the full results will be submitted for presentation at an upcoming international liver conference.