HTD1801: Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis(PSC) is chronic liver disease characterized by a progressive reduction or stoppage of bile flow with inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts

 Prevalence is 60 to 80 cases per 1 million population

 Occurs mostly (~70%) in men

 ~75% of PSC patients also have IBD

 Orphan indication with high unmet need

 No approved treatment

 Average life expectancy is 12-18 years without liver transplantation after diagnosis

 An over $10B market opportunity (US and EU)

How HTD1801 Should Help in PSC

Beneficial effects of HTD1801 in PSC are expected to include:

● Hepatocyte protection

● Anti-fibrosis

● Immunoregulation

● Intestinal microbiota modification

Based on a rat bile duct ligation (BDL) model of cholestasis, HTD1801:

● Lowered the elevated serum ALP levels

● Ameliorated hepatocellular necrosis

● Reduced inflammation in the portal area

● Inhibited bile duct proliferation

● Increased antioxidative defense

Market Overview

According tothe consulting firm CIC:


● The total diagnosed prevalent cases of primary sclerosing cholangitis (PSC) in China, the United States, and Europe are 281.1 thousand patients in 2022.

● The market size of PSC drugs in China, the United States, and Europe from 2028 to 2032 is that the field would expand at a compound annual growth rate (CAGR) of 121.2%.

For more information on the PSC trial, please visit


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