Pliant Therapeutics Initiates Phase 1 Clinical Study of PLN-74809

Development in Orphan Lung Disease Idiopathic Pulmonary Fibrosis Planned

SOUTH SAN FRANCISCO, CA, USA I January 3, 2019 I Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today 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.

"Based on positive preclinical studies, and shortly after submitting our first investigational new drug application, Pliant's first-in-human trial for PLN-74809 is underway and will inform further development of our novel, proprietary compound for the potential treatment of patients with idiopathic pulmonary fibrosis, a disease with very poor prognosis and few impactful treatment options," said Éric Lefebvre, M.D., chief medical officer of Pliant Therapeutics. "This study's results will also guide our development plans to evaluate PLN-74809 in other serious diseases where integrins are key drivers of fibrosis by activating TGF-β, including primary sclerosing cholangitis."

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 αVβ6 and αVβ1 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-β pathway. Proprietary small molecule PLN-74809 is an oral dual selective inhibitor of the αVβ6 and αVβ1 integrins. In preclinical studies, PLN-74809 modulates these fibrotic tissue-specific integrins, which selectively block activation of TGF-β, 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.

About Pliant Therapeutics
Pliant Therapeutics is a biotechnology company unraveling and targeting the key biological pathways driving fibrosis. By leveraging its powerful product discovery engine, Pliant's mission is to develop novel therapeutics that seek to halt progression of fibrotic diseases, ultimately preserving organ function. Founded by a group of seasoned experts in fibrosis biology, medicinal chemistry, translational medicine and clinical development, Pliant's lead product candidate PLN-74809 is being evaluated in a Phase 1 study to enable further development in idiopathic pulmonary fibrosis and other indications. Additional programs are expected to advance into the clinic in 2019. For more information, please visit www.pliantrx.com.

SOURCE: Pliant Therapeutics

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