Final Data Analysis of Phase 2 PBC Trial Shows that Genkyotex’s Anti-fibrotic Candidate GKT831 Demonstrated Statistically Significant Improvements in GGT and ALP Over Full Treatment Period
- Statistically significant reductions in GGT and ALP in 400mg BID dose over 24-week treatment period (p<0.002 and p<0.001, respectively)
- GKT831 400mg BID significantly improved multiple quality of life metrics important to PBC patients, including fatigue (p=0.027)
- Clean safety profile of GKT831 at all doses, with no safety signal identified over 24-week treatment period
- Previously reported data showed a 22% reduction in liver stiffness in PBC patients with liver fibrosis compared to a 4% increase for placebo (p=0.038), supports anti-fibrotic mechanism
Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX) announced today the final results of its Phase 2 trial of GKT831 in primary biliary cholangitis (PBC). These data include pre-determined secondary efficacy analyses that were not previously available, as well as full safety data.
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