GS-9674 is an investigational, selective and non-steroidal agonist of the (FXR), which is a nuclear hormone receptor that is highly expressed in the gastrointestinal tract and liver.
FXR is the primary regulator of bile acid synthesis and has significant roles in glucose and lipid metabolism.
The non-steroidal agonist is being studied to treat PSC, primary biliary cholangitis (PBC), and advanced fibrosis due to nonalcoholic steatohepatitis (NASH).
It has not yet secured approval from the US Food & Drug Administration (FDA) or any other regulatory authority
Gilead Sciences research and development head and chief scientific officer Dr John McHutchison said: “Gilead is committed to applying our research expertise in liver disease to address this debilitating condition which may lead to serious liver-related complications for PSC patients.
“These latest results from our Phase 2 program of GS-9674 are a positive step forward in the search for effective therapy.”
The company randomized GS-9674 100mg, GS-9674 30mg or placebo orally once daily for 12 weeks in the phase 2 double-blind and placebo-controlled trial.
Patients securing GS-9674 100mg have showed significant improvements in liver biochemistry tests after 12 weeks of treatment.
According to the company, the GS-9674 was well tolerated and the incidence of grade two or three pruritus was numerically lower with GS-9674 100mg and 30mg compared with placebo.
Separately, Gilead Sciences has also revealed latest data from viral hepatitis research programs.
The data from an open-label phase 2 study showed that treatment with the once-daily single-tablet regimen of Epclusa for 12 weeks in patients with genotype 1, 2, 3, 4 or 6 HCV and severe renal impairment undergoing dialysis resulted in cure rates of 95% with only two patients experiencing virologic failure.
The other open-label Phase 2 study showed that 97% of curing and none experiencing virologic failure in children aged three to five years old with genotype 1 or 4 HCV infection receiving weight-based oral dosing of ledipasvir/sofosbuvir granules 33.75 mg/150 mg.