Pliant Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for PLN-74809 for the treatment of primary sclerosing cholangitis (PSC), a rare, chronic and progressive liver disorder that often occurs in the setting of inflammatory bowel disease.

PLN-74809 is a dual selective inhibitor of the αVβ1 and αVβ6 integrins. The small molecule works by modulating these fibrotic tissue-specific integrins, which selectively block TGF-β activation, preventing growth of fibrotic tissue within the lung and liver. 

Earlier this year, the FDA granted Orphan Drug designation to PLN-70809 in the treatment of idiopathic pulmonary fibrosis (IPF). 

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“We expect to initiate our first clinical trial to support our lead indication of IPF before year-end, followed by studies in PSC to further investigate our approach of inhibiting integrins as a way to impact key drivers of fibrosis,” said Éric Lefebvre, MD, chief medical officer of Pliant Therapeutics.

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