Evidence that Allergan’s Phase III drug candidate, cenicriviroc, may benefit non-alcoholic steatohepatitis (NASH) patients was presented at the 2018 International Liver Congress (ILC) in Paris, France. Specifically, the results demonstrated that NASH patients who received cenicriviroc have a greater likelihood of a sustained reduction in liver fibrosis over two years compared with those who received placebo, supporting Allergan’s intention to market the drug as an anti-fibrosis agent in NASH patients.

Allergan’s cenicriviroc is an immunomodulatory that specifically targets two cellular mechanisms that are known to drive fibrosis. The drug has been investigated in a two-year, placebo controlled, Phase IIb clinical trial (CENTAUR), with the primary endpoint being a reduction in non-alcoholic fatty liver disease activity score (NAS), and the secondary endpoint being a reduction in fibrosis score, both measured after one and two years. Initial results from the one-year endpoint, published in 2017, demonstrated that although cenicriviroc did not meet the primary endpoint of NAS reduction, there was a significant reduction in fibrosis compared to the placebo group, leading to Allergan repositioning the drug candidate as an anti-fibrosis agent for NASH patients.

The clinical efficacy of cenicriviroc at the two year extended endpoint was presented at the 2018 ILC. Patients who had demonstrated a reduction in fibrosis after one year were found to be twice as likely to have maintained this reduction at the end of the second year if they were taking cenicriviroc rather than placebo. Furthermore, the efficacy of cenicriviroc was found to be similar in patients who were switched from the placebo arm to receive cenicriviroc at the end of the first year compared with those who had received the drug from the beginning of the study. After some disappointing results from the first year endpoint of the CENTAUR study, Allergan will be pleased that the year two results provide further evidence to support the use of cenicriviroc as an anti-fibrosis agent in NASH patients.

Further to the cenicriviroc efficacy data, an interesting ‘see-saw’ trend was observed in the placebo group during the second year of the study. Patients in the placebo arm who had a reduction in fibrosis during the first year of the study were found to be at the greatest risk of an increase in fibrosis during the second year. Likewise, patients taking the placebo who had an increase in fibrosis during the first year were found to have the greatest chance of a reduction in the second year. Because of this effect, the two year efficacy of cenicriviroc was found to be more significant than the one year efficacy, as many of the placebo patients relapsed.

GlobalData believes that other drug developers using fibrosis as a clinical endpoint for NASH may want to be bear in mind this ‘see-saw’ effect when designing trials, in order to ensure they improve the chances of demonstrating a significant increase in efficacy in the study drug arm.

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