GKT831, a NOX1&4 inhibitor, is the Company's most advanced product in development. Its pharmacodynamic activity and clinical safety profile support the development of GKT831 in many fibrotic diseases.
Genkyotex is currently finalizing a phase 2 study design for the treatment of primary biliary cholangitis (PBC), which is planned to start in H1 2017.
The data from the Phase 2 study in patient with diabetic kidney disease¹ showed a statistically significant effect on markers of liver injury and inflammation, confirming pre-clinical data obtained in multiple models of fibrotic disorders and providing the clinical foundation for the development of GKT831 in PBC.
¹ In September 2015 Genkyotex announced top-line data from its phase 2 clinical program with GKT831 in patients with diabetic kidney disease. GKT831 demonstrated an excellent safety profile and statistically significant reduction in both liver enzyme and inflammatory marker levels. Treatment with GKT831 for 12 weeks resulted in fewer adverse events than placebo, confirming its excellent safety profile. However, a reduction in albuminuria, the primary efficacy endpoint of the study, was not achieved within this timeframe