HTD1801: Nonalcoholic Steatohepatitis (NASH)

NAFLD/NASH (Nonalcoholic Fatty Liver Disease / Nonalcoholic Steatohepatitis) is a range of liver conditions affecting people who drink little to no alcohol.


As reported by the National Institutes of Health, Nonalcoholic fatty liver disease (NAFLD) is a condition in which excess fat is stored in the liver. This buildup of fat is not caused by heavy alcohol use. When heavy alcohol use causes fat to build up in the liver it is called alcoholic liver disease.

Two types of NAFLD are simple fatty liver and nonalcoholic steatohepatitis (NASH). Simple fatty liver and NASH are two separate conditions. People typically develop one type of NAFLD or the other, although sometimes people with one form are later diagnosed with the other form of NAFLD.

Simple fatty liver

Simple fatty liver, also called nonalcoholic fatty liver (NAFL), is a form of NAFLD in which you have fat in your liver but little or no inflammation or liver cell damage. Simple fatty liver typically does not progress to cause liver damage or complications.


NASH is a form of NAFLD in which you have hepatitis—inflammation of the liver—and liver cell damage, in addition to fat in your liver. Inflammation and liver cell damage can cause fibrosis, or scarring, of the liver. NASH may lead to cirrhosis or liver cancer.

Experts are not sure why some people with NAFLD have NASH while others have simple fatty liver.

How HTD1801 Should Help in NASH

As indicated by pharmacology studies in mouse, monkey, hamster and rat, HTD1801 should:

● Improve liver histology by decreasing:

the NAFLD Score (NAS)


ballooning degereration, steatosis

● Decrease liver cholesterol & triglyceride

● Decrease liver enzymes

● Decrease serum LDL-c

● Improve insulin sensitivity

As NASH is a complex disease, combination therapy in HTD1801 can address multiple targets and pathways, as depicted by the figure on the right.

Market Overview

According to MedCity News

A new report by research and consulting firm GlobalData has underscored the extreme blockbuster potential of nonalcoholic steatohepatitis (NASH).

Looking at the seven major markets (7MM) of the U.S., France, Germany, Italy, Spain, the U.K., and Japan, the authors determined that the field would expand at a compound annual growth rate (CAGR) of 45 percent.

That means that during the next 10 years, the field is projected to swell forty-fold from $618 million in 2016 to $25.3 billion in 2026.

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