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Pliant Therapeutics, Inc. (Nasdaq: PLRX) is a pioneering clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing breakthrough treatments for fibrotic diseases. The company leverages the therapeutic potential of integrin biology and TGF-β modulation to create therapies that could prevent or even reverse fibrosis, thereby addressing significant unmet medical needs.
Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule dual selective inhibitor of αvß6 and αvß1 integrins. It is currently in development for treating idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA for both IPF and PSC, as well as Orphan Drug Designation from the European Medicines Agency.
The company is actively advancing several clinical programs:
- INTEGRIS-PSC Phase 2a Trial: Recent interim results demonstrated bexotegrast’s potential in treating PSC, showing reductions in Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels with statistical significance at the 160 mg dose.
- BEACON-IPF Phase 2b/3 Trial: This adaptive trial design aims to accelerate the development timeline by immediately transitioning from Phase 2b to Phase 3 upon enrollment completion.
- PLN-1474: A small molecule selective inhibitor for treating nonalcoholic steatohepatitis (NASH) with liver fibrosis.
- PLN-101095: In Phase 1, this dual-selective inhibitor targets integrins αvß8 and αvß1 for treating solid tumors.
- PLN-101325: A monoclonal antibody agonist targeting muscular dystrophies.
Founded by world-renowned researchers from UCSF, Pliant Therapeutics combines expertise in fibrosis biology and small molecule chemistry to develop novel therapies. The company also aims to build a patient registry to enhance the understanding of fibrotic disease progression and to support biomarker discovery.
With a strong pipeline, significant regulatory designations, and ongoing successful clinical trials, Pliant Therapeutics is well-positioned to make substantial advancements in treating fibrotic diseases. For more information and the latest updates, visit their website or follow them on social media platforms like X, LinkedIn, Facebook, and YouTube.
Pliant Therapeutics (PLRX) announced the pricing of an upsized underwritten public offering of 10,810,811 shares at $18.50 each, aiming to raise approximately $200 million. The offering is set to close around July 15, 2022. The proceeds will support ongoing and future clinical programs, working capital, operating expenses, and capital expenditures. Underwriters have an option for an additional 1,621,621 shares. The offering is conducted under a previously effective SEC registration statement.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced a public offering of $150 million in common stock, with an optional $22.5 million for underwriters. The funds will support ongoing and future clinical programs, including PLN-74809, operational expenses, and development of their integrin targeting platform. The offering is subject to market conditions and regulatory approvals. J.P. Morgan and Cowen are leading the offering, with RBC Capital Markets acting as a book-running manager.
Pliant Therapeutics announced positive results from the INTEGRIS-IPF Phase 2a trial of PLN-74809 for idiopathic pulmonary fibrosis (IPF). The trial met its primary and secondary endpoints over 12 weeks, demonstrating a favorable safety profile with no drug-related serious adverse events. Notably, PLN-74809 showed a dose-dependent treatment effect, achieving an 80% reduction in forced vital capacity (FVC) decline compared to placebo. 97% of patients completed the trial without discontinuations due to adverse effects. The company plans to share results with regulatory authorities and anticipates interim data from an additional cohort in early 2023.
Pliant Therapeutics (PLRX) presented significant findings on its antifibrotic candidate, PLN-74809, at the International Liver Congress 2022. The posters highlighted the oral dual integrin inhibitor's favorable tolerability in the INTEGRIS-PSC study and its preclinical efficacy in reducing fibrosis markers in biliary fibrosis models. Results indicated dose-dependent reductions in liver fibrosis and TGF-β signaling, positioning PLN-74809 as a promising treatment for primary sclerosing cholangitis (PSC) and idiopathic pulmonary fibrosis (IPF). The ongoing Phase 2a trials aim to further evaluate the drug's impact.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) has presented promising preclinical data for PLN-101325, an allosteric antibody targeting the α7β1 integrin, at the New Directions in Biology and Disease of Skeletal Muscle Conference. The data indicates improved muscle function in dystrophic conditions, particularly in diaphragm strength, which could lead to better treatments for muscular dystrophies like Duchenne Muscular Dystrophy (DMD). An IND submission for PLN-101325 is expected by the end of 2022, with clinical trials anticipated to commence in early 2023.
Pliant Therapeutics (Nasdaq: PLRX) has announced the advancement of a fibrosis-directed integrin target into development, following a successful validation from its 2019 collaboration with Novartis. The company will receive a $4 million milestone payment alongside research funding to support the initiation of development activities. This milestone showcases Pliant's commitment to advancing therapies for fibrotic diseases, highlighting the productivity of its antifibrotic drug development platform.
Pliant Therapeutics (Nasdaq: PLRX) announced the presentation of two scientific posters at the International Liver Congress™ 2022 in London from June 22-26, 2022. The posters will focus on the dual inhibition of integrins αvß6 and αvß1 by PLN-74809 in treating primary sclerosing cholangitis (PSC).
The first poster highlights findings from preclinical studies, while the second investigates portal pressure and liver fibrosis in rats with biliary cirrhosis. The presentations will be available on-demand at Pliant's website.
Pliant Therapeutics (Nasdaq: PLRX) presented five scientific posters at the 2022 American Thoracic Society International Conference in San Francisco from May 13-18, 2022. The data showcased their lead product, PLN-74809, a dual-selective inhibitor aimed at treating idiopathic pulmonary fibrosis (IPF). Key findings included safety data indicating PLN-74809 was well-tolerated in over 450 subjects, with no severe adverse events. Interim results from Phase 2a trials demonstrated dose-dependent target engagement in IPF patients, reinforcing the therapeutic potential of PLN-74809.
Pliant Therapeutics (Nasdaq: PLRX), a clinical-stage biotechnology firm, announced that its President and CEO, Bernard Coulie, will participate in two investor conferences in May 2022. The RBC Capital Markets Global Healthcare conference will feature a fireside chat on May 18 at 10:00 a.m. ET, while a replay of the H.C. Wainwright Global Investment Conference chat will be available on May 23 at 7:00 a.m. ET. Interested parties can access these events on Pliant's Investor Relations page.
Pliant Therapeutics (Nasdaq: PLRX) provided a corporate update on May 9, 2022, announcing a $100 million loan facility from Oxford Finance that extends its cash runway to mid-2024. The company is advancing its clinical programs, notably the INTEGRIS-IPF Phase 2a trial for PLN-74809, expected to yield data in mid-2022. The drug received FDA Fast Track and EMA Orphan Drug designations for treating idiopathic pulmonary fibrosis and primary sclerosing cholangitis. Financially, R&D and G&A expenses increased, resulting in a net loss of $28.1 million for Q1 2022.
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