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Genkyotex Meets Primary, Secondary Interim Endpoints In Phase 2 Trial Of GKT831

Genkyotex said that its lead product candidate GKT831, a NOX1/4 inhibitor, met both the primary and secondary interim efficacy endpoints with high statistical significance after only 6 weeks of treatment. The data establish GKT831 as an attractive therapeutic option in a broad PBC population and support its development in multiple fibrotic diseases including NASH and IPF.

GKT831 achieved even greater GGT reductions (29%, p<0.01 vs placebo) in patients with higher baseline GGT (= 2.5 XULN, n=68), suggesting that it may also benefit patients with more advanced disease, the patient population with the highest medical need and limited therapeutic options.

In addition, the progressive reductions from baseline to week 2 and to week 6 suggest that further improvements can be achieved with continued treatment. Specifically, the 400mg twice daily dose (BID) achieved a 15% reduction in GGT at week 2 and a 23% reduction at week 6. ALP reductions were 12% at week 2 and 17% at week 6.

The interim analysis was conducted in 92 patients after 6 weeks of treatment. Final study results after 24 weeks of treatment in 111 PBC patients are expected in Spring 2019. The final results will also include additional endpoints assessing quality of life (fatigue and pruritus), fibrosis and cholestasis.

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