Christmas is a time of giving, and non-alcoholic steatohepatitis (NASH) is one disease that keeps on giving. Not only is it highly prevalent and increasingly so, but research and development in the field is flourishing. Indeed, the science surrounding NASH is evolving so rapidly that it was hard to keep track of all the new developments over the past year. It seemed there was not a week passed in 2016 without another novel agent being moved into clinical trials and set to become the next ‘big thing’. Which is a good thing because there are no current ‘things’ in NASH at all– there are no approved drug therapies. This widely prevalent liver disorder is fast becoming the dominant chronic liver disease and the leading reason for liver transplantation in the next few years. So the more potential drug candidates in the pipeline the better.

Along with the multitude of potential agents emerging have been numerous new drug targets. Lending weight to the multiple-hit hypothesis for NASH development and the thinking that NASH is the hepatic manifestation of the metabolic syndrome. NASH, type 2 diabetes, dyslipidemia, hypertension, and obesity have so much overlap in terms of metabolic dysregulation, it would not be a surprise that they are all essentially the same syndrome. However, whereas diabetes, hypertension, and dyslipidemia have various therapeutic options, obesity has only a few, and NASH has none, which begs the question: will fatty liver be as difficult to treat effectively as fat everywhere?

Leading the way are Intercept’s Ocaliva (obeticholic acid), already approved for primary biliary cholangitis, and Genfit’s elafibranor, which are both in Phase III, and there is now a plethora of novel compounds in Phase II and they will be needed. In the same way that multiple drugs targeting different pathways have become the norm for treating type 2 diabetes and hypertension, it makes sense that such an approach would be required for NASH. Gilead and Allergan appear to share this viewpoint and appear to be building a stable of agents that target different pathways contributing to the development of NASH. Time will tell if this approach will be successful, but the high rates of interest and activity in the field during 2016 provides hope. No single product appears to have a cure wrapped up, but perhaps it won’t be long before we have an armamentarium of therapies that can give NASH patients a better chance of avoiding complications.


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