SOUTH SAN FRANCISCO, Calif., Sept. 11, 2023 (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 presentations made at the European Respiratory Society (ERS) International Congress 2023 taking place from September 9, 2023 to September 13, 2023.

“We are pleased to be sharing non-clinical and clinical data at this important congress, including, for the first time at a scientific session, the final results from our INTEGRIS-IPF Phase 2a trial. Data from this trial support the late-stage development of bexotegrast as part of the BEACON-IPF trial and highlight our commitment to developing potential treatments for fibrotic diseases,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.

Safety, tolerability and antifibrotic activity of bexotegrast: Phase 2a INTEGRIS-IPF Study (NCT04396756)

Findings from the 24-week analysis of our recently completed INTEGRIS-IPF Phase 2a trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF) were presented in late-breaking oral and e-poster forms. Results showed that bexotegrast at 320 mg was well tolerated for up to 40 weeks of treatment with no discontinuations due to treatment-emergent adverse events occurring from Week 12 to Week 40. Additionally, over 24 weeks, a durable treatment effect on forced vital capacity (FVC) was observed in a population predominantly using IPF background therapies (nintedanib or pirfenidone). Quantitative lung fibrosis (QLF) imaging continued to demonstrate the antifibrotic mechanism of bexotegrast: at Week 24, the proportion of bexotegrast 320 mg-treated participants who experienced a stabilization or improvement of fibrosis was twice as high as those in the placebo group.

Dual αVβ6/αVβ1 integrin inhibitor bexotegrast reduces fibrogenesis in pathological cell populations present in the fibrotic human lung

Results from a single nuclei RNASeq analysis of bexotegrast-treated precision-cut lung slices prepared from fibrotic human tissue were presented in oral and poster forms. Results showed that bexotegrast treatment reduced the expression of pro-fibrogenic genes and pathways in pro-fibrotic (CTHRC1+) fibroblasts, as well as in aberrant basaloid cells known to express integrin α_Vβ₆.

Circulating ITGB6 levels are elevated in patients with IPF and reduced following lung transplant

Results from a study comparing serum concentrations of integrin β6 in patients with IPF (pre/post-transplant) and healthy subjects was presented in poster form. Results showed that serum concentrations of integrin β6 were significantly elevated in patients with IPF compared to healthy controls, and that levels were significantly reduced in patients with IPF following lung transplant. Further analysis of circulating integrin β6 in clinical trials may help to better characterize its utility as an early biomarker of response to anti-fibrotic therapy.

Posters presented at the 2023 ERS International Congress are also available on Pliant’s website under the Publications section at https://pliantrx.com/publications.

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, 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, a Phase 2b trial of bexotegrast in IPF. Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 integrin for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant has initiated 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 to clinical stage programs, Pliant currently has a preclinical program targeting muscular dystrophies. For additional information, please visit: www.PliantRx.com. Follow us on social media 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 safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our plans for the future development of bexotegrast, PLN-101325 and PLN-101095; bexotegrast’s potential to become a treatment for IPF or PSC; the anticipated timing of data and progress from our clinical studies; discussions with regulatory authorities; the sufficiency of our cash runway to fund operations into the second half of 2026. 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 lingering effects of the 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, 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 three months ended June 30, 2023 which 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 Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
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