Non-alcoholic Steatohepatitis (NASH), although one of the leading causes for liver transplant is a mostly forgotten disease. Despite being prevalent in 3-5% of the US population NASH has no targeted treatments.
Yet now there is a race to be the first. NASH has become a lively arena for development in the last few years with Gilead, Intercept, Genfit and Shire (to name but a few) putting their hats in the ring. The leader currently is Intercept, having already had their candidate approved for use in NASH. However, no treatment has managed to be approved by the FDA, with many trials being fast tracked (not Intercept's) there could be a chance for Gilead to monopolise the US market, if Genfit's phase III trial does not show clinical significance.
This experimental compound, GS-0976, from Gilead has shown signs of improving liver fibrosis. As an inhibitor of acetyl-coA carboxylase if used in early stage patients it could prevent further inflammation and fat build up within the liver stemming the progression of the disease. However, with its findings on liver stiffness, serum ALT and a serum marker for fibrogenesis not being statistically significant it could be unlikely to find designation in later stage disease.
“Unfortunately, there are no treatments available for these patients. In this first randomised, placebo-controlled, Phase II study of an ACC inhibitor in NASH, the data suggest that GS-0976 has the potential to play an important role in treating patients with this disease.”