Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Association for the Study of the Liver (EASL) International Liver Congress™
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.
- Positive interim results from Phase 2a trial of bexotegrast in PSC.
- Bexotegrast well-tolerated across all dose cohorts over 12 weeks.
- Reduction in enhanced liver fibrosis scores and type III collagen formation.
- Unique targeting of TGF-β signaling in fibrogenic cells.
- Validation of bexotegrast’s antifibrotic mechanism.
- Interim results mean final efficacy and safety still unconfirmed.
- to a 12-week interim analysis; long-term effects unknown.
- Data from Phase 2a trial, not yet advanced to Phase 3.
Insights
Pliant Therapeutics' recent data on bexotegrast offers promising insights into the drug's potential for treating fibrotic liver diseases, particularly primary sclerosing cholangitis (PSC). The Phase 2a INTEGRIS-PSC trial interim results, showing that bexotegrast was well tolerated and demonstrated antifibrotic effects, is a significant milestone. For investors, the key points to note are the positive topline results and the specific targeting of TGF-beta signaling, a important pathway in fibrosis. Understanding that TGF-beta is a master regulator of fibrogenic activities, the ability of bexotegrast to selectively inhibit this pathway in liver tissue suggests fewer side effects and better safety profiles compared to broader inhibitors. This could place Pliant Therapeutics in a strong competitive position within the fibrotic disease treatment market.
Nonetheless, while short-term impacts on the stock might be positive due to the promising interim results, the long-term outlook will depend on the final outcomes of the trial, regulatory approvals and eventual market adoption. Investors should watch for further data releases and FDA feedback.
The positive topline data from the Phase 2a INTEGRIS-PSC trial could lead to increased investor confidence and potentially boost Pliant's stock price in the short term. The company's emphasis on novel therapeutic pathways and the drug's demonstrated efficacy in interim results provide a solid foundation for future growth. However, investors should remain cautious as the transition from Phase 2 to Phase 3 trials often involves significant capital expenditure and the risk of unforeseen setbacks. Additionally, the biotech sector is highly sensitive to clinical trial outcomes and regulatory decisions, which can cause stock volatility. Monitoring the company's cash burn rate, upcoming milestones and strategic partnerships will be vital for assessing long-term financial health.
The fibrotic disease market is highly competitive, with multiple companies aiming to address unmet clinical needs in liver diseases. Bexotegrast’s unique mechanism of action, targeting specific integrins and TGF-beta signaling pathways, differentiates it from other treatments. This could translate into a significant market advantage if subsequent trials confirm its safety and efficacy. Furthermore, the demand for effective PSC treatments is high due to the lack of FDA-approved therapies, offering a potentially lucrative opportunity for Pliant Therapeutics. However, market penetration will depend on clinical outcomes, pricing strategies and the ability to gain physician and patient adoption. Investors should keep an eye on competitor developments and Pliant's strategic plans for commercializing bexotegrast.
SOUTH SAN FRANCISCO, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced two poster presentations, including a late-breaker, were presented at the European Association for the Study of the Liver (EASL) International Liver Congress™ being held June 5-8, 2024.
“We were pleased to share our latest data from our bexotegrast program in PSC including positive topline results from our Phase 2a INTEGRIS-PSC trial. These data represent the progress we continue to make in advancing this novel drug in fighting fibrotic liver disease. We look forward to presenting additional data from INTEGRIS-PSC in the coming weeks,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics.
In a late breaker oral presentation, Michael Trauner, M.D., Chair of Gastroenterology and Hepatology, Department of Medicine III at the Medical University Clinic in Vienna, Austria presented interim results from the ongoing randomized, placebo-controlled Phase 2a INTEGRIS-PSC trial. Results showed that bexotegrast was well tolerated across all dose cohorts over 12 weeks of treatment. Across all doses tested, bexotegrast attenuated increases in enhanced liver fibrosis (ELF) scores and pro-peptide of type III collagen formation (PRO-C3) when compared to placebo supporting bexotegrast’s antifibrotic mechanism of action.
In a poster presentation, Johanna Schaub, Ph.D., Principal Scientist II, Translational Sciences, at Pliant Therapeutics presented results from differential gene expression analysis of bexotegrast in human precision-cut liver slices with biliary fibrosis performed at the single cell level. Inhibition with bexotegrast showed a differentiated profile from TGF-β receptor (ALK5) inhibition. Bexotegrast targeted reduction of TGF-β signaling, a master regulator in fibrosis, in fibrogenic cells, with attenuated effects on cell types associated with the immunomodulatory functions of TGF-β.
Posters presented at the 2024 (EASL) International Liver Congress™ are available on Pliant’s website under the Publications section at https://pliantrx.com/publications.
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a late-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. 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, an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is conducting 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, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies.
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Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com
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