Pliant Therapeutics Reports Positive Results for Bexotegrast in IPF Trial

Pliant Therapeutics announces positive topline results from a Phase 2a clinical trial of bexotegrast, a potential disease-modifying therapy for idiopathic pulmonary fibrosis (IPF), showing a reduction in total lung collagen and improvements in lung function in patients with IPF. The trial, conducted at Massachusetts General Hospital, demonstrates the antifibrotic mechanism of action of bexotegrast, offering promise for a new treatment option for this debilitating disease." This description focuses on the primary topic (bexotegrast and its potential as a treatment for IPF), the main entities (Pliant Therapeutics, Massachusetts General Hospital), the context (clinical trial), and the significant actions and implications (positive topline results, potential disease-modifying therapy). The description also provides objective and relevant details that will help an AI generate an accurate visual representation of the article's content, such as the setting of the trial and the key outcomes.

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Aqsa Younas Rana
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Pliant Therapeutics Reports Positive Results for Bexotegrast in IPF Trial

Pliant Therapeutics Reports Positive Results for Bexotegrast in IPF Trial

Pliant Therapeutics Inc. (NASDAQ: PLRX) announced on Tuesday positive topline results from a Phase 2a clinical trial evaluating bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). The 12-week trial, conducted at Massachusetts General Hospital, showed that treatment with bexotegrast 160mg led to a reduction in total lung collagen compared to placebo.

The trial enrolled 10 patients with IPF, with 7 patients receiving bexotegrast and 3 patients receiving placebo. Patients underwent positron emission tomography (PET) imaging with a collagen-binding radiotracer at baseline and at 12 weeks to measure changes in lung collagen levels. The primary endpoint was the change in standardized uptake value (SUV) of 68Ga-CBP8, a PET ligand that binds to type 1 collagen.

Why this matters: This breakthrough in IPF treatment has the potential to improve the quality of life for millions of people worldwide suffering from this debilitating disease. A disease-modifying therapy like bexotegrast could also reduce the economic burden on healthcare systems and families affected by IPF.

In addition to the reduction in total lung collagen, patients treated with bexotegrast demonstrated improvements in forced vital capacity (FVC) and a reduction in cough severity compared to placebo across all timepoints. Bexotegrast was well-tolerated over the 12-week treatment period, with no serious adverse events reported and no discontinuations due to adverse events.

"These imaging data continue to demonstrate the antifibrotic mechanism of action of bexotegrast and build on previous results, including from our INTEGRIS-IPF Phase 2a trial," said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. "Results from this first study using collagen PET imaging to assess a therapeutic intervention highlight the possible utilization of this novel technology to identify potentially disease-modifying antifibrotic IPF therapies in short-term studies," added Sydney Montesi, M.D., Clinician Researcher, Division of Pulmonary and Critical Care Medicine at Massachusetts General Hospital and Principal Investigator in the trial.

IPF is a chronic, progressive, fibrosing lung disease of unknown cause, characterized by the histopathologic pattern of usual interstitial pneumonia. The disease commonly affects adults over the age of 50 and is associated with high morbidity and mortality, with a median survival of 3-5 years from diagnosis. Current approved therapies slow disease progression but do not halt or reverse lung fibrosis or improve lung function.

Bexotegrast is an investigational, small molecule, dual selective inhibitor of αVβ6 and αVβ1 integrins in development for the treatment of fibrotic diseases. In preclinical studies, bexotegrast exhibited antifibrotic activity across a range of models, including in lung, liver, and kidney fibrosis. The results from this Phase 2a PET imaging trial provide further evidence of bexotegrast's potential as a disease-modifying therapy for IPF and support its continued clinical development.

The positive topline data from this Phase 2a trial mark an important milestone for Pliant Therapeutics and the development of bexotegrast. The ability to demonstrate a reduction in lung collagen and improvements in clinically meaningful outcomes like FVC in a short 12-week study offers promise for bexotegrast's potential to make a meaningful difference for patients suffering from IPF. The company plans to advance bexotegrast into late-stage clinical development, with a Phase 2b trial in IPF anticipated to begin in the first half of 2025.

Key Takeaways

  • Pliant Therapeutics' bexotegrast shows promise in treating idiopathic pulmonary fibrosis (IPF).
  • Phase 2a trial results: reduced lung collagen, improved lung function, and reduced cough severity.
  • Bexotegrast was well-tolerated with no serious adverse events reported.
  • IPF affects millions worldwide, with high morbidity and mortality rates.
  • Phase 2b trial in IPF anticipated to begin in H1 2025.