Pliant discontinues Phase 2b/3 trial of IPF treatment bexotegrast
Decision comes after safety board review, expert panel recommendation
Pliant Therapeutics has discontinued a pivotal Phase 2b/3 clinical trial evaluating its idiopathic pulmonary fibrosis (IPF) treatment bexotegrast due to safety issues.
The BEACON-IPF (NCT06097260)Â trial was assessing whether once-daily doses of bexotegrast (160 mg or 320 mg) could improve lung function in about 360 IPF patients, ages 40 and older, when compared with a placebo.
Pliant’s decision to halt the study was made following a pre-planned review of trial data by the trial’s independent data safety monitoring board and a recommendation by an outside expert panel, according to a company press release.
Bexotegrast, formerly known as PLN-74809, is a small molecule designed to inhibit two proteins — alpha v beta 6 and alpha v beta 1 — found at high levels in the lungs of people with IPF. These proteins are believed to play a role in the development of scar tissue, and by blocking them, bexotegrast aims to slow, stop, or potentially reverse lung scarring, or fibrosis.
IPF treatment showed early promise
In BEACON-IPF, patients were exposed to the therapy for a mean of 17 weeks. While the rate of IPF-related side effects was similar between the two tested doses (around 10%), there was a notable difference between patients receiving bexotegrast and those given the placebo. This difference was primarily due to an unusually low rate of side effects (less than 3%) in the placebo group.
In the Phase 2a INTEGRIS-IPF trial (NCT04396756), which tested multiple doses of bexotegrast against a placebo, the rate of IPF-related side effects was more balanced between patients receiving bexotegrast (7%) and those given the placebo (10%).
The company said the BEACON-IPF study is the first late-stage IPF clinical trial to be discontinued due to safety reasons while showing promising signs of efficacy. According to Pliant, there was early evidence bexotegrast had a positive effect on lung function.
Pliant said it will review the complete data from BEACON-IPF. Based on this analysis, it may proceed with additional dose-ranging Phase 2b studies to test lower doses of bexotegrast for treating pulmonary fibrosis and possibly other diseases, such as liver conditions.
The company said it is “committed to the development of its other clinical and pipeline assets.”
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