PLRX Pliant Therapeutics Inc

Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, announced its presentations at the European Respiratory Society (ERS) International Congress 2024 taking place in Vienna, Austria September 7 - 11, 2024.

“Presentations made by Pliant colleagues and investigators at the 2024 ERS Congress include additional clinical data from our recently announced type 1 collagen PET imaging study, an integrated safety summary from our INTEGRIS clinical programs and non-clinical data from our bexotegrast development program. Taken together, these data provide further support for the late-stage development of this novel therapeutic as part of our ongoing BEACON-IPF trial,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.

Bexotegrast reduces type 1 collagen deposition in participants with idiopathic pulmonary fibrosis (IPF) after 12 weeks of therapy

In a late-breaker oral presentation, Sydney B. Montesi, M.D., Assistant Professor of Medicine at Massachusetts General Hospital, Havard Medical School presented results from the first interventional Phase 2, single-center, randomized, double-blind, placebo-controlled trial (NCT05621252) evaluating type 1 collagen deposition by positron emission tomography (PET) imaging in the lungs of participants with IPF. Following 12 weeks of treatment, bexotegrast demonstrated a reduction in type 1 collagen in contrast to an increase on placebo, supporting bexotegrast’s antifibrotic effects and suggesting favorable lung remodeling. In addition, treatment with bexotegrast showed numerical improvements in forced vital capacity, cough severity, and prognostic biomarkers, suggesting its potential for disease modification in idiopathic pulmonary fibrosis (IPF). Lastly, measurements by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), bexotegrast demonstrated an increased peak enhancement and a faster contrast washout rate, suggesting improvements in lung microvasculature and decreased extravascular extracellular volume, further supporting the PET imaging findings.

Safety and tolerability of bexotegrast in Phase 2 trials of idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC)

In an oral presentation, Gregory Cosgrove, M.D. FCCP, Vice President of Clinical Development at Pliant Therapeutics presented an integrated safety summary of bexotegrast from the INTEGRIS Phase 2a trials in IPF and primary sclerosing cholangitis (PSC). Results showed that, at 12 weeks of treatment, bexotegrast was well tolerated with no related serious adverse events with most adverse events being mild to moderate with low discontinuation rates across both trials.

Bexotegrast is antifibrotic in precision cut-lung slices prepared from fibrotic interstitial lung disease explants

In a late-breaker oral presentation, Johanna Schaub, Ph.D., Principal Scientist II, Translational Sciences at Pliant Therapeutics, presented a study assessing the antifibrotic effects of bexotegrast, a dual αvβ6/αvβ1 integrin inhibitor, in precision cut-lung slices from patients with progressive fibrosing interstitial lung diseases (ILD) other than IPF. Results showed that integrin αvβ6 levels were increased in lungs from patients with a diverse set of fibrotic ILDs and that bexotegrast decreased profibrogenic gene expression in lung slices generated from a wide range of ILD lung explants. In addition, the antifibrotic activity of bexotegrast was found to be similar in slices from IPF and non-IPF explants. These data support the further investigation into the antifibrotic activity of bexotegrast in ILD-associated progressive pulmonary fibrosis (PFF).

Post-hoc biomarker analysis in participants with IPF receiving bexotegrast over 12-weeks in INTEGRIS-IPF

In a poster presentation, Martin Decaris, Ph.D., Senior Director, Translational Sciences at Pliant Therapeutics, presented results from a post-hoc proteomic analysis of plasma samples from the INTEGRIS-IPF Phase 2a clinical trial of bexotegrast in patients with IPF. Results showed that plasma levels of several previously identified biomarkers of ILD progression, including integrin beta-6, were reduced in participants receiving bexotegrast at the 320 mg dose versus placebo. Plasma integrin beta-6 levels were also found to negatively correlate with changes in lung function as determined by percent predicted forced vital capacity (FVCpp). Further analyses of plasma biomarkers are included as part of the ongoing global Phase 2b/3 BEACON-IPF trial.

Posters presented at the ERS International Congress 2024 are available on Pliant’s website under the Publications section at https://pliantrx.com/publications.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a late-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF, an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies.

For additional information, please visit: www.PliantRx.com. Follow us on social media: X, LinkedIn, and Facebook.

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 potential for the future development of bexotegrast. 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 current macroeconomic and marketplace conditions, including the effects of COVID-19, 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, including the availability of additional term loans under our loan facility, 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 Quarterly Report on Form 10-Q for the period ended June 30, 2024 which we filed with the SEC on August 7, 2024, and is 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 KeenanVice President, Investor Relations and Corporate CommunicationsPliant Therapeutics, Inc.ir@pliantrx.com