Policy & Regulation
Genkyotex's GKT831 succeeds in a phase two trial in primary biliary cholangitis
7 November 2018 -

France-based Genkyotex's NOX1/4 inhibitor, GKT831, has succeeded in a phase two trial in primary biliary cholangitis, a form of liver disease, by meeting both primary and secondary interim efficacy endpoints, it was reported yesterday.

The product recorded high statistical significance following six weeks of treatment, according to the French biotech company.

The 24-week placebo-controlled trial is being held across multiple countries in 111 primary biliary cholangitis patients having inadequate response to ursodeoxycholic acid. The primary efficacy endpoint of the mid-stage trial is change in gamma glutamyl transpeptidase (GGT) at week 24. The company stated that GKT831 delivered even greater gamma glutamyl transpeptidase reductions, of 29% in patients with higher baseline GGT.

The company said that the progressive reductions from baseline to week 2 and to week 6 indicate that further improvements can be reached with continued treatment with GKT831.



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