Genkyotex picks out silver linings from failed PhII, braces for pivotal study in primary biliary cholangitis
Genkyotex’s Phase II primary biliary cholangitis trial was mainly supposed to measure reduction in gamma glutamyl transpeptidase (CGT). But that may not be obvious if you just read the company’s release on the topline efficacy results.
That’s likely because their drug, a NOX1&4 inhibitor dubbed GKT831, failed the primary endpoint. They did report a 19% reduction in CGT, but it’s not statistically significant after 24 weeks. Yet what the French biotech would like to spotlight are the secondary endpoints — a statistically significant reduction in alkaline phosphatase (p=0.002) and, for a subgroup of patients who had more severe fibrosis to start with, a 22% reduction in liver stiffness compared to a 4% increase in placebo (p=0.038).
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