Pliant Therapeutics Initiates First-in-Human Clinical Trial of PLN-1474 for the Potential Treatment of Liver Fibrosis

SOUTH SAN FRANCISCO, CA — March 23, 2020 — Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of serious fibrotic diseases, today announced that it has dosed the first cohort of healthy participants in a first-in-human Phase 1 clinical trial of PLN-1474, a small molecule selective inhibitor of integrin αVβ1, currently being developed for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The PLN-1474 development program is currently partnered with Novartis.

“PLN-1474 has demonstrated compelling preclinical evidence in models of NASH and liver fibrosis. We look forward to further investigating this compound, alongside Novartis, in this dose-escalating Phase 1 study.” said Éric Lefebvre, M.D., chief medical officer of Pliant Therapeutics. “We believe our differentiated approach of inhibiting the TGF-β activation pathway via integrin blockade in the liver holds the potential to provide clinically meaningful antifibrotic benefits to individuals living with NASH and clinically advanced liver fibrosis.”

Pliant previously announced a strategic collaboration with Novartis for a worldwide exclusive license to PLN-1474 and up to three additional product candidates. Pliant will be responsible for the development of PLN-1474 through Phase 1.  After Phase 1, Novartis will assume responsibility for all future development, manufacturing and commercialization.

NASH associated cirrhosis is the fastest growing indication for liver transplantation in the United States. Many patients with NASH develop associated liver fibrosis, which can lead to complications such as cirrhosis and ultimately liver failure. While multiple investigational agents target mechanisms that impact the earlier metabolic stages of the NASH continuum, Pliant is targeting clinically advanced liver fibrosis associated with NASH through inhibition of αvβ1, an integrin that activates TGF-β, a putative master regulator of hepatic fibrosis.

About PLN-1474
Pliant’s approach focuses on fibrotic tissue-specific inhibition of integrins and the TGF-β pathway. PLN-1474, a small molecule selective inhibitor of the αVβ1 integrin, is currently being evaluated for the treatment of NASH with liver fibrosis through a partnership with Novartis. In preclinical studies, PLN-1474 was observed to selectively block the αvβ1 integrin mediated activation of TGF-β, reducing fibrosis in the liver.

About Pliant Therapeutics

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel targeted therapies to slow or halt the progression of life-threatening fibrotic diseases. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6, two integrins that play key roles in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and is currently in Phase 2 testing for IPF. Pliant’s second product candidate, PLN-1474, is designed to be a small molecule selective inhibitor of αvβ1, targeting liver fibrosis associated with nonalcoholic steatohepatitis (NASH) and is partnered with Novartis.  PLN-1474 is currently in Phase 1 testing. For more information, please visit www.pliantrx.com.

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Cambria Fuqua

Canale Communications

(619) 849-5390

cambria@canalecomm.com