Allergan has reported positive top-line two-year results from its Phase IIb CENTAUR clinical trial of Cenicriviroc (CVC) to treat liver fibrosis in adults suffering from non-alcoholic steatohepatitis (NASH).
The firm announced one-year results from the trial last year and the latest data is obtained from patients treated for two years and those who switched from placebo to CVC after one year.
CVC is an oral, once-daily, potent immunomodulator currently being developed to block the CCR2 and CCR5 chemokine receptors involved in NASH’s inflammatory and fibrogenic pathways that lead to liver damage, cirrhosis, liver cancer or liver failure.
According to the results, 20% of patients who crossed over to CVC treatment in the second year achieved the combined endpoint of a decrease in fibrosis by a minimum of one stage with no worsening of NASH, while 35% achieved improvement in fibrosis by at least one stage.
The multinational, randomised, double-blind, placebo-controlled CENTAUR trial compared the safety and anti-fibrotic efficacy of CVC with placebo in 289 NASH patients with liver fibrosis.
Allergan chief research and development officer David Nicholson said: “We have gained important insights from this analysis which will further support our progress with CVC.
“The CENTAUR trial is a first of its kind with three biopsies in patients with NASH disease and liver fibrosis.”
The results also showed that patients who remained on CVC for two years did not demonstrate a significant difference in fibrosis reduction but had higher baseline fibrosis scores with better outcomes.
Additionally, the two-year safety data was found to be comparable with placebo and consistent with the first-year findings.
The new data is said to support CVC’s ongoing Phase III AURORA trial in 2,000 subjects, with the primary composite endpoint being fibrosis reduction by a minimum of one stage without NASH worsening at one year.