Twice-daily dose of Genkyotex's PBC therapy meets six-week endpoints

Genkyotex S.A. (Euronext:GKTX) reported data from a prespecified interim analysis of 92 evaluable patients with primary biliary cholangitis in a Phase II trial showing that twice-daily GKT831 led to a significant 23% reduction in mean γ glutamyl transpeptidase (GGT) levels from baseline to week six vs. 7% for placebo (p<0.01). The once-daily dose of GKT831 led to a non-significant 12% reduction on the endpoint vs. placebo (p=0.52).

CEO Elias Papatheodorou told BioCentury that Genkyotex hopes to start Phase III testing of the dual NADPH oxidase 1 (NOX1) and NOX4 inhibitor to treat PBC as close as possible to the Phase II trial’s final readout, which is planned for spring 2019...