Pliant Therapeutics has discontinued the bexotegrast development for idiopathic pulmonary fibrosis (IPF) following a review of data from the terminated global, double-blind, randomised, placebo-controlled BEACON-IPF Phase IIb/III trial.
The decision was influenced by the trial’s full efficacy and safety data analysis involving 160mg and 320mg doses of the therapy, which indicated an unfavourable risk-benefit profile.
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In March 2025, the company announced the voluntary discontinuation of the BEACON-IPF based on recommendations and prespecified data review by the independent Data Safety Monitoring Board (DSMB) and an external expert panel, which noted an imbalance in IPF-related adverse events among participants.
The therapy led to an increased risk of adverse events related to the progression of IPF disease against placebo.
These included worsening of IPF, acute exacerbation, all-cause death, and respiratory-related hospitalisation.
Subjects treated by the therapy had an average time to disease progression of 33 weeks.
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By GlobalDataHowever, at week 12, the 160mg and 320mg therapy groups showed improvements in forced vital capacity (FVC) decline of 72mL and 46mL, respectively against placebo.
At week 24, the improvements in FVC decline were observed as 58mL and 8mL for 160mg and 320mg groups, respectively.
Pliant plans to submit the full outcomes from the BEACON-IPF trial for future publication.
Pliant Therapeutics CEO and president Bernard Coulie said: “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.
“We sincerely thank all patients, their caregivers, the study investigators and their research teams who were part of the BEACON-IPF clinical programme for their extensive efforts.”
Meanwhile, the company continues to advance a Phase I open-label trial assessing PLN-101095, an oral small molecule inhibitor, as a single agent in solid tumours resistant to immune checkpoint inhibitors.
The company’s early-stage platform encompasses preclinical research on tissue-specific delivery and internalisation of drug payloads leveraging integrin receptor-binding molecules.
