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)
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
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%.
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