Biopharmaceutical company HighTide Therapeutics Inc revealed on Tuesday the receipt of the US FDA Fast Track Designation to facilitate the development and expedite the review of its investigational new drug HTD1801 for the treatment of patients with nonalcoholic steatohepatitis (NASH).
A form of nonalcoholic fatty liver disease (NAFLD), NASH is a chronic, complex liver disease characterised by hepatitis - inflammation of the liver - and liver cell damage, which can lead to fibrosis of the liver. NASH can lead to cirrhosis and liver cancer.
The company said HTD1801 is a new molecular entity being developed for the treatment of PSC (primary sclerosing cholangitis) and NASH. It has completed a first in human study of HTD1801 in healthy volunteers. A multi-centre Phase 2 trial in adult patients with NASH is scheduled to enrol soon in the US.
Currently, a multi-centre Phase 2 trial in adult patients with PSC is ongoing in the US, concluded the company.
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