Genkyotex begins Phase II of GKT831 in PBC

Genkyotex S.A. (Euronext:GKTX) began a Phase II trial to evaluate once- and twice-daily 400 mg GKT831 (formerly GKT137831) for 24 weeks in 102 patients with primary biliary cholangitis (PBC) and an inadequate response to ursodeoxycholic acid.

The double-blind, placebo-controlled, international trial’s primary endpoint is reduction in gamma glutamyl transpeptidase. Secondary endpoints include liver inflammation and fibrosis, bile acid metabolism, itching, autoimmunity, quality of life (QOL), safety and pharmacokinetics...