Pliant Therapeutics Initiates Phase 1 Clinical Study of PLN-74809
January 03, 2019 at 08:00 am EST
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Pliant Therapeutics, Inc. announced that it has dosed the first cohort of subjects in a Phase 1 clinical study evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of anti-fibrotic agent PLN-74809. This randomized, double-blind, placebo-controlled, single and multiple ascending oral dose study will enroll approximately 90 healthy participants. The primary objective is the assessment of the safety and tolerability to PLN-74809 after a single dose and following 14 days of dosing. The study also includes evaluation of pharmacokinetics and exploratory assessments of biomarkers related to the activity of the aVß6 and aVß1 integrins, the target of PLN-74809 treatment. About PLN-74809: Pliant's therapeutic approach focuses on fibrotic tissue-specific inhibition of integrins and the TGF-ß pathway. Proprietary small molecule PLN-74809 is an oral dual selective inhibitor of the aVß6 and aVß1 integrins. In preclinical studies, PLN-74809 modulates these fibrotic tissue-specific integrins, which selectively block activation of TGF-ß, preventing the growth of fibrotic tissue within the lung. Pliant also expects to evaluate PLN-74809 in other fibrotic diseases with unmet clinical needs, including primary sclerosing cholangitis (PSC), a chronic progressive disorder characterized by inflammation and fibrosis of the bile ducts in the liver. The U.S. Food and Drug Administration has granted orphan drug designation to PLN-74809 for the indications of idiopathic pulmonary fibrosis and primary sclerosing cholangitis.
Pliant Therapeutics, Inc. is a clinical-stage biotechnology company. The Company is focused on discovering and developing therapies for the treatment of fibrosis and related diseases. Its lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvÃ6 and αvÃ1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). The Company has initiated BEACON-IPF, a Phase 2b trial of bexotegrast in IPF. It has also developed PLN-1474, a small molecule, selective inhibitor of αvÃ1 integrin for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis. It has initiated a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvÃ8 and αvÃ1 integrins, that is being developed for the treatment of solid tumors. The Company has a preclinical program, PLN-101325, targeting muscular dystrophies.