The liver is one of the largest and most complex organs in the body. It stores vital energy and nutrients, manufactures proteins and enzymes necessary for good health, protects the body from disease, and breaks down (or metabolizes) and helps remove harmful toxins from the body.

Fatty liver disease, or non-alcoholic fatty liver disease (NAFLD) patients have unhealthy dietary intakes characterized by overconsumption of fructose and soft drinks, lower consumption of fiber, overconsumption of meat, saturated fat and cholesterol, lower consumption of fish or omega-3 fatty acids, and low consumption of some vitamins. A high fructose consumption increases the risk of fibrosis in NASH patients

Non-alcoholic steatohepatitis (NASH) is a common and serious chronic liver disease that develops in approximately thirty percent of NAFLD patients who have excessive fat accumulation in the liver (steatosis). NASH is caused by steatosis that induces inflammation and may lead to progressive fibrosis and cirrhosis, followed by eventual liver failure and death. There are currently no drugs approved for the treatment of NASH.

While NASH is commonly associated with obesity, it can also occur in non-obese patients and has been linked in both developed and developing countries to the adoption of a diet with increased consumption of processed foods containing polyunsaturated fatty acids and fructose. Cardiovascular disease, cancer and liver failure are the most common causes of death in NASH patients. More than 20% of NASH patients progress to cirrhosis within a decade of diagnosis and, with the rapidly increasing prevalence of the disease, NASH has become the second most common reason for liver transplant in the United States and is projected to become the leading indication for transplant in the next few years, overtaking both chronic HCV infection and alcoholic liver disease. NASH patients have a ten-fold greater risk of liver-related mortality as compared to the general population and a six-fold greater risk of liver-related mortality as compared to patients with less severe NAFLD. The presence of type 2 diabetes in the broader NAFLD population is associated with a much greater mortality risk, with a 23-fold higher rate of liver-related mortality as compared to non-diabetic NAFLD patients.

NASH is believed to be one of the most common chronic liver diseases worldwide, with an estimated prevalence of more than 10% of the general adult population in the United States, with similar prevalence estimated in Europe, Japan and other developed countries. Additionally, NASH has become a highly prevalent liver disease in developing countries such as India and China. According to recent epidemiological studies, it is estimated that more than 60% of NASH patients (potentially more than 14 million in total in the U.S.) believed to have liver fibrosis or cirrhosis due to progression of the disease. Although the prevalence of NASH is lower in children, it has also become a serious disease burden in the pediatric population.