Pliant Therapeutics Halts Key Fibrosis Drug Trial, Stock Plummets Amid Uncertainty

Pliant Therapeutics voluntarily paused enrollment and dosing in its Phase 2b/3 BEACON-IPF trial for bexotegrast, a drug candidate for idiopathic pulmonary fibrosis (IPF)15.

The pause followed a recommendation from the independent Data Safety Monitoring Board (DSMB) after a routine data review14.

Pliant's stock price fell by more than 60% following the announcement, dropping to around $3 per share, its lowest level since the company's IPO in 202012.

The specific reasons for the DSMB's recommendation are currently unclear, with Pliant reviewing data to understand the rationale15.

Pliant has initiated the assembly of an outside panel of experts to review the trial data and provide an independent recommendation4.

The BEACON-IPF trial was designed to enroll about 360 participants and test whether bexotegrast could slow or halt disease progression after a year of treatment1.

Several financial institutions, including JPMorgan and Wells Fargo, have downgraded Pliant's stock rating and significantly reduced price targets7.

Bexotegrast is a dual-selective blocker of αvβ6 and αvβ1 integrins, proteins involved in the activation of profibrotic cytokine TGF-β5.

The setback raises uncertainty about the future of a program that was closely watched due to its potential in treating IPF, a rare lung condition that has long challenged drugmakers1.

Pliant expects the review process by the expert panel to conclude in two to four weeks4.

Sources:

1. https://www.biopharmadive.com/news/pliant-idiopathic-pulmonary-fibrosis-study-halt/739653/

2. https://www.nasdaq.com/articles/pliant-therapeutics-pauses-enrollment-and-dosing-beacon-ipf-trial-stock-freefall

4. https://www.biospace.com/press-releases/pliant-therapeutics-announces-next-steps-following-dsmb-recommendation-on-beacon-ipf-a-phase-2b-3-trial-in-patients-with-idiopathic-pulmonary-fibrosis

5. https://www.biospace.com/drug-development/pliant-stock-crashes-after-suspension-of-idiopathic-pulmonary-fibrosis-study

7. https://www.investing.com/news/analyst-ratings/jpmorgan-cuts-pliant-therapeutics-stock-rating-to-neutral-93CH-3859538

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