New data in nonalcoholic steatohepatitis ( NASH ) were presented at The International Liver Congress 2019 in Vienna.
The data support the development of the combination therapies to target different aspects of NASH.
A proof-of-concept study has demonstrated that the combination of the investigational, selective, non-steroidal farnesoid X receptor ( FXR ) agonist Cilofexor and the acetyl-CoA carboxylase ( ACC ) inhibitor Firsocostat resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers.
In the study, 20 patients with NASH received Cilofexor 30 mg and Firsocostat 20 mg orally once daily for 12 weeks.
A significant decline of at least 30% in hepatic fat measured by magnetic resonance imaging-proton density fat fraction ( MRI-PDFF ) from baseline to 12 weeks was observed in 74% of patients.
Improvements in liver biochemistry tests including serum ALT ( median relative reduction, -37%; p less than 0.001 ) and GGT ( -32%; p less than 0.001), along with markers of reduced bile acid synthesis, were observed at 12 weeks.
Treatment was well tolerated and pruritus was not reported in any patients. Asymptomatic, grade 3 hypertriglyceridemia was observed in two patients.
No patients withdrew from the study due to adverse events. ( Xagena )
Source: Gilead, 2019