About MASH
MASH (Metabolic dysfunction-associated steatohepatitis) is a progressive, inflammatory condition in which excess fat in the liver drives chronic inflammation and liver injury. Over time this can advance to fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma, and it substantially increases risk for cardiovascular disease, which is the leading cause of death in this population. MASH is tightly linked to metabolic health: more than 80% of patients are overweight or obese, and many have type 2 diabetes. It is estimated that approximately 30 million people in the United States will have MASH by 2030, yet the condition remains underdiagnosed because it is largely silent until at an advanced stage.i,ii MASH is the leading cause for liver transplants in women and those over the age of 65 in the United States and is projected to become the number one cause of liver transplantation in all population categories.iii Because the disease is driven by both liver and metabolic dysfunction, MASH treatments should directly target the liver to reduce inflammation and fibrosis, while providing improvements in cardiometabolic risk factors, including weight loss.
About AUD
AUD (Alcohol use disorder) is a chronic, relapsing medical condition characterized by an impaired ability to stop or control alcohol use despite adverse health, social, or occupational consequences. It is among the most common substance use disorders in the United States: an estimated 27.9 million people ages 12 and older (about 9.7% of that population) met criteria for AUD in the past year, and 66% of patients have obesity or are overweight.iv,v AUD can lead to the accumulation of excess liver fat in up to 90% of individuals, leading to steatosis (fatty liver) and liver dysfunction. It is the primary driver of alcohol-associated liver disease and contributes to a wide range of other health harms. Yet, AUD remains substantially undertreated, with only a small fraction of affected individuals receiving pharmacologic therapy.v Alcohol use in patients with MASH can also accelerate inflammation and fibrosis and contribute substantially to disease progression.
About ALD
ALD (Alcohol-associated liver disease) is a spectrum of liver injury caused by chronic excessive alcohol use, ranging from alcohol-associated steatohepatitis to fibrosis, cirrhosis, and hepatocellular carcinoma. A subset of ALD patients progress to steatohepatitis and cirrhosis. ALD accounts for a large share of cirrhosis cases in the U.S. and has become a leading indication for liver transplantation. Its burden is rising sharply with U.S. age-adjusted ALD mortality roughly doubling between 1999 and 2022, with especially steep increases among women and adults aged 25–44. There are currently no FDA-approved therapies specifically for ALD, underscoring a significant unmet need.vi,vii