(RTTNews) - Pliant Therapeutics, Inc. (PLRX) announced the discontinuation of its BEACON-IPF Phase 2b trial evaluating bexotegrast for the treatment of idiopathic pulmonary fibrosis or IPF following a review by the independent Data Safety Monitoring Board or DSMB and an external expert panel.
The decision was based on an imbalance in IPF-related adverse events between the treatment and placebo groups, although early evidence of efficacy on the forced vital capacity or FVC endpoint was observed.
While the trial was discontinued for safety concerns, the companies noted that this is the first late-stage IPF trial to be halted for safety while showing strong evidence of efficacy.
The mean exposure duration in the study was approximately 17 weeks, with IPF-related adverse events observed in both dose groups.
The imbalance appeared to be driven by a low rate of IPF-related events in the placebo group, compared to the active treatment groups.
Pliant plans to conduct a full analysis of the trial data to better understand the benefit-risk profile of bexotegrast.
The company will consider further studies with lower doses of the drug in pulmonary fibrosis and potentially other diseases, including liver diseases.
In addition, Pliant continues its work on other pipeline assets, including PLN-101095, a drug currently being tested in a Phase 1 trial for solid tumors.
The company remains committed to advancing innovative treatments for fibrotic diseases and oncology.
Currently, PLRX is trading at $2.57, down by 25.29 percent on the Nasdaq.
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