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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 (Nasdaq: PLRX) presented data from its bexotegrast program at the European Respiratory Society International Congress 2024. Key findings include:
1. Reduction in type 1 collagen deposition in IPF patients after 12 weeks of bexotegrast treatment, suggesting antifibrotic effects and favorable lung remodeling.
2. Integrated safety summary showing bexotegrast was well-tolerated in Phase 2a trials for IPF and PSC.
3. Preclinical data demonstrating antifibrotic effects in lung slices from various ILD patients, supporting further investigation in ILD-associated progressive pulmonary fibrosis.
4. Post-hoc biomarker analysis revealing reduced levels of ILD progression markers in IPF patients receiving bexotegrast.
Pliant Therapeutics (Nasdaq: PLRX), a clinical-stage biotechnology company focused on developing novel therapeutics for fibrotic diseases, has announced its participation in four major investor events in September 2024. These include:
1. 2024 Wells Fargo Healthcare Conference on September 4
2. H.C. Wainwright 26th Annual Global Investment Conference on September 11
3. 2024 Cantor Global Healthcare Conference on September 17
4. Stifel 2024 Virtual Immunology and Inflammation Summit on September 18
Key executives, including the CEO, CFO, and CMO, will participate in fireside chats at these events. Live webcasts will be available on Pliant's Investor Relations website, with replays archived for 30 days after each event.
Pliant Therapeutics (Nasdaq: PLRX) announced four upcoming presentations at the European Respiratory Society (ERS) International Congress 2024 in Vienna, Austria from September 7-11, 2024. The presentations focus on bexotegrast, a dual αVβ6/αVβ1 integrin inhibitor for treating fibrotic diseases.
Key presentations include:
- Evaluation of bexotegrast's antifibrotic activity in non-IPF interstitial lung disease
- Bexotegrast's effect on type 1 collagen deposition in IPF patients after 12 weeks
- Safety and tolerability of bexotegrast in Phase 2 trials for IPF and primary sclerosing cholangitis
- Post-hoc biomarker analysis in IPF patients receiving bexotegrast over 12 weeks
These presentations highlight Pliant's progress in developing novel therapeutics for fibrotic diseases, particularly idiopathic pulmonary fibrosis (IPF).
Pliant Therapeutics (Nasdaq: PLRX) reported positive results from its Phase 2a PET imaging trial for bexotegrast in IPF patients, showing reduced lung collagen, improved FVC, and reduced cough severity. The company also shared positive long-term data from the INTEGRIS-PSC 320 mg cohort, demonstrating continued antifibrotic and anti-cholestatic activity at 24 weeks.
The BEACON-IPF Phase 2b trial is on track for full enrollment in Q1 2025, with data expected mid-2026. Pliant's pipeline includes PLN-101095 for solid tumors and PLN-101325 for muscular dystrophies. Financially, Q2 2024 saw R&D expenses of $45.6 million, G&A expenses of $15.0 million, and a net loss of $55.9 million. The company ended the quarter with $438.1 million in cash and investments.
Pliant Therapeutics (Nasdaq: PLRX) announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event will feature a fireside chat with Keith Cummings, M.D., Chief Financial Officer, and Éric Lefebvre, M.D., Chief Medical Officer. The chat is scheduled for Wednesday, August 14, 2024, at 1:00 p.m. Eastern Time at the Intercontinental Hotel in Boston, Massachusetts.
Interested parties can access a live webcast of the fireside chat through Pliant's website Investor Relations' Events & Presentation page. A replay of the webcast will be available on the company's website for 30 days after the event concludes.
Pliant Therapeutics (Nasdaq: PLRX) announced positive 24-week data from the 320 mg cohort of INTEGRIS-PSC, a Phase 2a trial of bexotegrast in primary sclerosing cholangitis (PSC) patients. Key findings include:
1. Safety: Bexotegrast was well-tolerated up to 40 weeks with no treatment-related severe or serious adverse events.
2. Efficacy: Improvement in liver stiffness at Week 24 compared to placebo, statistically significant improvement in alkaline phosphatase (ALP) levels, and continued improvement in hepatocyte function and bile flow.
3. FDA Guidance: The FDA supports a 52-week, dose-ranging Phase 2b trial using non-invasive endpoints for the next steps in PSC development.
These results suggest bexotegrast's potential for disease stabilization in PSC, a rare liver disease with no FDA or EMA-approved therapies.
Pliant Therapeutics (Nasdaq: PLRX) has appointed Steve Krognes to its Board of Directors as announced on June 13, 2024. Krognes brings over 30 years of financial and corporate strategy experience in the biopharmaceutical industry. His prior roles include Chief Financial Officer at Denali Therapeutics and Genentech, and Global Head of Mergers and Acquisitions at Roche. Krognes' financial expertise and strategic leadership are expected to complement Pliant’s existing board, aiding in the company's evolution as a late-stage clinical entity. Currently, Krognes serves on several other boards, including Denali Therapeutics, Guardant Health, argenx, and ClavystBio. He holds an MBA from Harvard Business School and a B.S. in Economics from Wharton School, University of Pennsylvania.
Pliant Therapeutics (Nasdaq: PLRX) announced an inducement grant under Nasdaq Listing Rule 5635(c)(4) on June 12, 2024. The company granted stock options for 120,000 shares to Dr. Chohee Yun, the newly appointed Senior VP of Clinical Development. These options have an exercise price of $11.51 per share, aligned with the closing price on June 10, 2024. The options will vest over four years: 25% on the first anniversary and the remainder monthly over the next three years. The options have a 10-year term and are governed by the 2022 Inducement Plan.
Pliant Therapeutics presented promising data on their drug bexotegrast at the EASL International Liver Congress. Key findings included positive interim results from the Phase 2a INTEGRIS-PSC trial, showing that bexotegrast was well tolerated and effective in reducing markers of liver fibrosis over 12 weeks. Additionally, bexotegrast demonstrated a unique mechanism of action in targeting fibrogenic cells and inhibiting TGF-β signaling. These results further validate bexotegrast's potential as a treatment for fibrotic liver disease.
Pliant Therapeutics presented key data on their drug bexotegrast at the American Thoracic Society 2024 International Conference. The data includes clinical safety, imaging, and preclinical results supporting late-stage development of the drug for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). Dr. Gregory P. Cosgrove highlighted that bexotegrast has been well tolerated in over 700 participants across 15 trials with mostly mild to moderate adverse events. Dr. Mahru C. An shared that bexotegrast effectively targets TGF-beta signaling in fibrogenic cells. Dr. Martin L. Decaris reviewed a post-hoc analysis showing significant modulation of plasma biomarkers in IPF patients over 12 weeks. Lastly, Dr. Jonathan G. Goldin reported a reduction in lung fibrosis progression and no increase in alveolar inflammation in bexotegrast-treated patients over 24 weeks.
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