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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, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology firm, announced participation in the 22nd Annual Needham Virtual Healthcare Conference on April 19, 2023, at 3:45 p.m. ET. Bernard Coulie, M.D., Ph.D., President and CEO, and Éric Lefebvre, M.D., Chief Medical Officer, will engage in a fireside chat accessible via their Investor Relations page. Pliant's lead product, bexotegrast, is focused on treating idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and has received Fast Track and Orphan Drug Designations. They are also advancing programs for nonalcoholic steatohepatitis (NASH) and solid tumors, with ongoing Phase 2a trials.
Pliant Therapeutics (PLRX) announced it will present three scientific posters at the 2023 American Thoracic Society (ATS) International Conference from May 19-24, 2023, in Washington, DC. Highlights include data from the Phase 2a trial of bexotegrast (PLN-74809), a dual-selective integrin inhibitor being developed for idiopathic pulmonary fibrosis (IPF). Two of the presentations have been selected for featured oral presentations. The company emphasizes the drug's mechanism of action and its ongoing clinical development, which has received FDA Fast Track and Orphan Drug Designations.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) has received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue its INTEGRIS-PSC Phase 2a trial for bexotegrast, a dual-selective integrin inhibitor. The trial will now advance to a 320 mg dose group, enrolling patients for 24 to 48 weeks. Over 600 participants have been treated with no severe adverse events reported. The trial addresses the unmet medical need for primary sclerosing cholangitis (PSC), and interim results from initial dose groups are expected in Q3 2023. The company emphasizes the potential of bexotegrast and its commitment to developing therapies for fibrosis-related diseases.
Pliant Therapeutics (PLRX) announced positive interim data from its Phase 2a INTEGRIS-IPF trial for bexotegrast, showing a favorable safety profile and significant increases in forced vital capacity (FVC) at 12 weeks. The company completed a $287.5 million equity financing, extending its cash runway into 2026. Further data from the 320 mg dose group is expected in Q2 2023, along with initiation of a Phase 1 trial for PLN-101095 in solid tumors. Research and development expenses rose to $25.1 million, while net loss increased to $35.1 million in Q4 2022. As of December 31, 2022, PLRX had $331.2 million in cash and equivalents.
Pliant Therapeutics (Nasdaq: PLRX) announced the appointments of Darren Cline and Thomas McCourt to its Board of Directors, effective March 8, 2023. These appointments are expected to bolster the company’s commercial and operational strategies as it advances its clinical programs, particularly in fibrosis treatment. Cline has over 30 years of experience in the pharmaceutical industry, previously holding key roles at Epygenix Therapeutics and GW Pharmaceuticals. McCourt brings significant expertise from his leadership at Ironwood Pharmaceuticals, where he oversaw the launch of the blockbuster product LINZESS. The company aims to leverage their insights to bring transformative therapies to market.
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a biotechnology firm focused on fibrosis therapies, announces participation in key investor events in March 2023. Leadership, including President Bernard Coulie, will engage in fireside chats at the Cowen 43rd Annual Health Care Conference on March 8 and the Oppenheimer 33rd Annual Healthcare Conference on March 13. An invitation-only meeting with investors will also occur on March 23 as part of the Citi West Coast Biotech Bus Trip. Pliant's lead candidate, bexotegrast, aimed at treating idiopathic pulmonary fibrosis and primary sclerosing cholangitis, has received multiple FDA designations, with Phase 2a trials underway.
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a biotechnology firm focused on fibrosis therapies, has announced participation in key investor events in February 2023. Notably, members of the senior management will engage at the SVB Securities Global Biopharma Virtual Conference on February 14, including a fireside chat featuring CFO Keith Cummings and CMO Éric Lefebvre on February 15 at 3:40 p.m. ET. Additionally, Pliant will present at the Citi Biotech C-Suite Fireside Chat Series on February 22 at 3:00 p.m. ET, with President Bernard Coulie and CMO Lefebvre. Pliant's lead product, bexotegrast (PLN-74809), targets idiopathic pulmonary fibrosis and has received multiple designations from the FDA and EMA.
Pliant Therapeutics (Nasdaq: PLRX) announced FDA clearance for its Investigational New Drug application for PLN-101095, a novel small molecule dual selective inhibitor. This phase 1 clinical study will focus on patients with solid tumors resistant to immune checkpoint inhibitors, set to begin in Q2 2023. PLN-101095 aims to resensitize tumors to PD(L)-1 inhibitors by targeting integrins αvβ8 and αvβ1 in the tumor microenvironment. This study marks the company's third program advancing into clinical trials, highlighting their commitment to addressing cancer treatment gaps. Details on safety and preliminary efficacy will follow as the trial progresses.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced the completion of its upsized underwritten public offering, closing on 9,583,334 shares of common stock sold at $30.00 per share. This offering, which included the underwriters’ option to purchase an additional 1,250,000 shares, raised approximately $287.5 million in gross proceeds. The funds will be utilized to support ongoing and future clinical programs, including bexotegrast and PLN-101095, as well as general corporate purposes. J.P. Morgan and Piper Sandler served as lead managers for the offering.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) has appointed Ms. Lily Cheung as its new Chief Human Resources Officer. With over 25 years of experience, including 15 years in commercial-stage companies, Cheung previously held senior HR roles at Synthekine and Rigel Pharmaceuticals. Her expertise is expected to enhance the company's culture and make it an attractive workplace. Pliant is focused on developing therapies for fibrosis, with its lead candidate, bexotegrast (PLN-74809), currently in Phase 2a trials for idiopathic pulmonary fibrosis and primary sclerosing cholangitis. The company has received FDA Fast Track and Orphan Drug Designations for this candidate.
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