Pliant discontinues bexotegrast for IPF due to safety concerns

SOUTH SAN FRANCISCO - Pliant Therapeutics, Inc. (NASDAQ:PLRX), whose shares have plunged over 90% in the past six months to $1.25, has discontinued development of bexotegrast for idiopathic pulmonary fibrosis (IPF) following a review of data from its terminated BEACON-IPF Phase 2b/3 clinical trial, the company announced Friday. According to InvestingPro data, the company’s market capitalization has dropped to approximately $79 million, with the stock trading near its 52-week low of $1.10.

The trial was voluntarily halted in March after an independent Data Safety Monitoring Board and an outside expert panel identified an imbalance in IPF-related adverse events. Subsequent analysis revealed an unfavorable risk-benefit profile at both the 160 mg and 320 mg doses.

Data showed bexotegrast-treated participants faced increased risk of adverse events associated with IPF disease progression compared to placebo. The average time to disease progression was 33 weeks for those receiving the drug.

While bexotegrast demonstrated some improvements in forced vital capacity (FVC) decline at Week 12, with the 160 mg dose showing a statistically significant improvement of 72 mL compared to placebo, these benefits diminished by Week 24.

"Although the decision to discontinue bexotegrast in IPF is disappointing for us and the many patients in need of new treatment options, we believe it is the right decision to protect patient safety," said Bernard Coulie, President and Chief Executive Officer of Pliant.

The company will continue development of its oncology program, including PLN-101095, currently in Phase 1 trials for solid tumors resistant to immune checkpoint inhibitors. Interim results announced in March showed the drug was generally well tolerated with confirmed partial responses in 50% of patients at the highest dose tested. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 11.03, though it’s rapidly burning through cash reserves. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial metrics to make informed investment decisions.

Pliant also continues work on PLN-101325 for muscular dystrophies and its early-stage programs supported by its proprietary integrin-based therapeutics platform.

The information in this article is based on a company press release.

In other recent news, Pliant Therapeutics announced a significant workforce reduction of approximately 45% as part of a strategic restructuring aimed at extending its financial resources and supporting late-stage clinical trials. The company is awaiting topline data from its BEACON-IPF Phase 2b/3 trial for the treatment candidate bexotegrast, which is expected in the second quarter of 2025. Additionally, Pliant Therapeutics presented new data on its antifibrotic treatment, bexotegrast, at the American Thoracic Society 2025 International Conference. The studies highlighted bexotegrast’s ability to inhibit fibrogenesis in lung tissue and its effectiveness in reducing the expression of profibrotic genes.

Furthermore, Pliant Therapeutics recently held an Annual Meeting where stockholders approved an amendment to the company’s Certificate of Incorporation, limiting the liability of certain officers. The amendment aligns with Delaware law and reflects stockholders’ support for the company’s governance and executive compensation structure. The stockholders also ratified Deloitte & Touche LLP as the independent auditor for the fiscal year ending December 31, 2025. These recent developments underscore Pliant Therapeutics’ ongoing efforts in corporate governance and therapeutic advancements.

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