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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) presented clinical data for bexotegrast, their oral integrin inhibitor, at The Liver Meeting® 2024. The Phase 2 INTEGRIS-PSC trial results showed that bexotegrast was well-tolerated and demonstrated antifibrotic and anti-cholestatic activity in primary sclerosing cholangitis (PSC) patients. The drug improved liver stiffness, Enhanced Liver Fibrosis scores, liver biochemistry, and MRI results.
Additionally, the company presented research identifying novel inflammatory biomarkers for PSC through proteomic screening, discovering potential serum and urine biomarker candidates that could help predict disease progression.
Pliant Therapeutics (PLRX) reported Q3 2024 financial results and provided updates on its clinical programs. The company's BEACON-IPF Phase 2b/3 trial for bexotegrast in IPF patients remains on track for full enrollment in Q1 2025, with data expected mid-2026. Q3 financial results showed R&D expenses of $47.8M (up from $32.3M YoY), G&A expenses of $14.3M (down from $15.3M YoY), and a net loss of $57.8M (increased from $41.5M YoY). The company maintains a strong cash position of $406.0M as of September 30, 2024.
Pliant Therapeutics (Nasdaq: PLRX) announced its participation in the upcoming Stifel 2024 Healthcare Conference. Chief Financial Officer Keith Cummings, M.D., and Greg Cosgrove, M.D. FCCP, will engage in a fireside chat on Tuesday, November 19, 2024, at 8:35 a.m. Eastern Time. The event will take place at the Lotte New York Palace Hotel in New York.
A live webcast will be available through Pliant's website Investor Relations' Events & Presentation page, with a replay accessible for 30 days after the event.
Pliant Therapeutics (Nasdaq: PLRX), a late-stage biotechnology company focused on fibrotic diseases, has appointed Gary Palmer, M.D., MBA as Senior Vice President of Medical Affairs. Dr. Palmer, with over 25 years of global leadership experience, will lead the company's global medical affairs activities, including scientific communications and patient advocacy.
Dr. Palmer's extensive background includes leadership roles at Bristol Myers Squibb, where he led the Worldwide Immunology, Fibrosis and Neuroscience Medical Affairs team. He has also held senior positions at Myovant Sciences, Actelion, Eisai Pharmaceuticals, and Pfizer. His expertise spans pulmonary medicine, immunology, and neurology, with experience in supporting successful and orphan disease products.
Éric Lefebvre, M.D., Chief Medical Officer at Pliant, highlighted Dr. Palmer's experience in building best-in-class Medical Affairs organizations as beneficial for Pliant's growth and portfolio advancement towards commercial stage.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) has announced the granting of stock options to Gary Palmer, M.D., the company's newly appointed Senior Vice President of Medical Affairs. The grant, made on September 30, 2024, includes options to purchase 120,000 shares of common stock as a material inducement to his employment.
The stock options have an exercise price of $11.21 per share, equal to the closing price of Pliant's common stock on the grant date. The options will vest over 4 years, with 25% vesting on the one-year anniversary and the remaining shares vesting monthly at a rate of 1/48th over the subsequent 36 months. The stock options have a 10-year term and are subject to the terms and conditions of the Company's 2022 Inducement Plan.
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.
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