Genkyotex announced the final results of its Phase 2 trial of GKT831 in primary biliary cholangitis (PBC). These data include pre-determined secondary efficacy analyses that were not previously available, as well as full safety data. The efficacy results demonstrate that GKT831 at the 400mg twice a day (BID) dose achieved statistically significant reductions in gamma glutamyl transpeptidase (GGT) (p1.5XULN) and elevated gamma glutamyl transpeptidase (GGT; >1.5 XULN). A total of 111 patients were allocated according to a 1:1:1 randomization ratio to three groups: UDCA plus placebo, UDCA plus GKT831 400mg OD and UDCA plus 400mg BID. The primary efficacy endpoint was percent change in GGT at week 24. Liver fibrosis was assessed non-invasively by measuring liver stiffness and circulating markers of fibrogenesis. Additional key secondary endpoints included additional markers of liver and bile duct injury, markers of inflammation. In addition, indicators of QoL, including pruritus and fatigue, were assessed. Markers of bile acid metabolism and immune activation were also investigated. Liver stiffness was measured by Fibroscan transient elastography. Liver stiffness is an indicator of liver inflammation (edema), cholestasis and fibrosis. In multiple liver diseases, including PBC, NASH and PSC, liver stiffness correlates with liver fibrosis stage (F0 to F4). In PSC, increases in liver stiffness are associated with adverse disease outcomes, including liver transplant, hepatic complication and death.