Pliant Therapeutics Announces Presentations at the International Liver Congress™ 2022 Highlighting Preclinical and Clinical Data in Support of the INTEGRIS-PSC Phase 2a Clinical Trial

SOUTH SAN FRANCISCO, Calif., June 24, 2022 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the presentation of two scientific posters at the International Liver Congress™ (ILC) 2022 of the European Association for the Study of the Liver (EASL), taking place June 22-26, 2022, in London, United Kingdom.

“Our presentations at this year’s International Liver Congress summarize the translational research findings supporting the hepatic antifibrotic activity of PLN-74809, an oral dual α_vß₆ / α_vß₁ integrin inhibitor,” said Éric Lefebvre, M.D., Chief Medical Offer at Pliant Therapeutics. “Preliminary safety data from the INTEGRIS-PSC study continue to show a favorable tolerability profile for PLN-74809.”

The poster “Rationale for Evaluation of PLN-74809 Treatment in Participants with Primary Sclerosing Cholangitis in Phase a Study INTEGRIS-PSC” summarized preclinical data on the antifibrotic activity of PLN-74809 in two preclinical models of biliary fibrosis as well as in precision-cut liver slices from patients with primary sclerosing cholangitis (PSC) or primary biliary cirrhosis (PBC). Results showed dose-dependent reductions of key drivers of fibrosis in a mouse model of biliary fibrosis including hepatic collagen, collagen proportionate area, TGF-β signaling and cholestasis. In precision-cut liver slices, PLN-74809 reduced TGF-β-driven COL1A1 and COL1A2 gene expression in a dose-dependent manner. In addition, PLN-74809 demonstrated a favorable tolerability profile based on available blinded safety data and pharmacokinetic findings from participants with PSC enrolled in Part 1 of the ongoing Phase 2a INTEGRIS-PSC study (NCT04480840) that evaluated a once-daily dose of 40 mg. The evaluation of PLN-74809 at doses of 80 mg and 160 mg is currently underway.

The poster “Dual Inhibition of Integrins α_vß₆ and α_vß₁ Decreases Portal Pressure and Liver Fibrosis in Rats with Biliary Cirrhosis” reviewed preclinical data showing that PLN-75068, a dual α_vß₆ / α_vß₁ inhibitor tool compound, reduced TGF-β signaling in the livers of rats with biliary cirrhosis as measured by the reduction of SMAD2 phosphorylation. In addition, a dose-dependent decrease in liver fibrosis, as assessed by collagen proportionate area (CPA), was observed along with dose-dependent inhibitory effects on the TGF-β target genes Ctgf, Serpine1 and SMAD7. Lastly, PLN-75068 improved portal hypertension in this biliary cirrhosis model.

Posters presented at the ILC 2022 are available under the Publications section of Pliant’s website at www.PliantRx.com.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant’s lead product candidate, PLN-74809, is an oral small molecule dual selective inhibitor of α_vß₆ and α_vß₁ integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and Orphan Drug Designation from the FDA and European Medicines Agency in PSC. Pliant is currently conducting Phase 2a trials of PLN-74809 in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small molecule selective inhibitor of α_vß₁ for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to our development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant Therapeutics, visit www.pliantrx.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the de-risking of our development of PLN-74809 and the efficacy and safety profile of our product candidates. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, our reliance on third parties for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K filed for the year ended December 31, 2021 with the SEC on March 1, 2022, as updated by our Quarterly Report on Form 10-Q filed for the quarter ended March 31, 2022 with the SEC on May 9, 2022, each available on the SEC’s website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Investor and Media Contact:

Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
[email protected]