Non-alcoholic fatty liver disease (NAFLD) is a condition in which excess fat is stored in the liver. This build-up of fat is not caused by heavy alcohol use. Two types of NAFLD are simple fatty liver and non-alcoholic steatohepatitis (NASH). Simple fatty liver and NASH are two separate conditions, and people typically develop one or the other. NASH is characterized by inflammation of the liver (hepatitis) and liver cell damage. Inflammation and liver cell damage can cause scarring (fibrosis) of the liver leading to cirrhosis. NASH may lead to other complications such as decompensated cirrhosis of the liver, in which the liver no longer functions, and liver cancer.
Selonsertib is an investigational oral small molecule inhibitor of ASK1, a protein that mediates inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH. NASH currently has no effective treatment apart from lifestyle interventions. If licensed, selonsertib will offer a new treatment option for NASH as no effective pharmacological therapies currently exist.
Ustekinumab is a drug which is given as an injection and works by blocking the molecules that are involved in the inflammation which occurs in UC. Ustekinumab is already licenced for use in people with Crohn’s disease, which is another type of IBD. If ustekinumab is licenced this would provide another treatment option for people with moderate to severe active UC.