Pliant Therapeutics Reduces Lung Collagen in IPF Trial

Pliant Therapeutics, Inc. (NASDAQ: PLRX) has released positive topline data from a phase 2a collagen PET imaging clinical trial of Bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The 12-week treatment with Bexotegrast 160 mg resulted in a reduction of total lung collagen as measured by PET imaging, compared to an increase on the placebo.

The trial evaluated Bexotegrast at a once-daily dose of 160 mg versus placebo and measured change in total lung collagen in 10 patients with IPF after 12 weeks of treatment. The trial enrolled 7 patients in the active arm and 3 in the placebo arm, with 8 out of 10 enrolled patients on standard of care, with the majority of those on nintedanib.

The primary endpoint of the trial was an evaluation of the change in standardized uptake value (SUV) of 68Ga-CBP8, a PET ligand that binds to type 1 collagen. After 12 weeks of treatment, Bexotegrast-treated patients showed a reduction in SUV in the lung compared to an increase seen in the placebo, indicating reduced total lung collagen in the treated group, suggesting potential reversal of fibrosis.

Bexotegrast-treated patients demonstrated improvements in forced vital capacity (FVC), forced vital capacity percent predicted (FVCpp), patient-reported cough severity, and fibrosis biomarkers across all time points. Additionally, patients treated with Bexotegrast showed a reduction in circulating biomarkers integrin beta-6 and pro-c3 relative to placebo.

The trial's secondary endpoint was the evaluation of the safety and tolerability of Bexotegrast. It was well tolerated at a dose of 160 mg over 12 weeks of treatment with no serious adverse events reported. The most frequently reported treatment-emergent adverse events were mild in severity with no trial discontinuations.

The results from this trial suggest the potential of Bexotegrast as a disease-modifying antifibrotic IPF therapy. Pliant Therapeutics is a late-stage biopharmaceutical company and a leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Their lead product candidate, Bexotegrast, has received fast track designation and orphan drug designation from the U.S. Food and Drug Administration in IPF and primary sclerosing cholangitis (PSC).

The company has initiated the beacon-IPF, a phase 2b/3 trial of Bexotegrast in IPF, and 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. Additionally, Pliant has received regulatory clearance for the conduct of a phase 1 study of PLN-101325, a monoclonal antibody against integrin α7ß1 targeting muscular dystrophies. The market has reacted to these announcements by moving the company's shares 2.2% to a price of $13.97. For the full picture, make sure to review Pliant Therapeutics's 8-K report.

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