Results of FLINT trial of OCA for NASH are published in The Lancet- Intercept Pharma

The results of the FLINT trial of OCA (obeticholic acid) for the treatment of Non Alcoholic Steatohepatitis from Intercept Pharma were published in The Lancet. In FLINT, OCA was superior to placebo for the primary outcome of improved liver histology (p = 0.0002) as well as the secondary endpoint of fibrosis improvement by at least one stage (p=0.004). Additionally, significant OCA treatment effects were demonstrated on the major histological features of NASH, including steatosis (p=0.001), lobular inflammation (p=0.006) and hepatocellular ballooning (p=0.03). Notably, post-hoc subgroup analyses found that the histological improvements were consistently greater in patients with more advanced disease and at greatest risk of progressing to liver failure and death. OCA was generally well tolerated in the FLINT trial, with pruritus occurring more frequently and at a higher grade in the OCA treatment group. The number of severe or life threatening events was not different compared to placebo.

Concerns were expressed at side effects that included increased cholesterol (LDL) and puritus. Future trials will have to address these concerns.