Pliant Announces Positive Data From Phase 2a Trial Of Bexotegrast In Idiopathic Pulmonary Fibrosis

Pliant Therapeutics Inc. (PLRX) announced positive data from the INTEGRIS-IPF phase 2a trial demonstrating bexotegrast (PLN-74809) 320 mg was well tolerated and achieved statistically significant forced vital capacity increase in patients with idiopathic pulmonary fibrosis.

The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile, the company said in a statement.

The trial's exploratory efficacy endpoints assessed changes in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging and biomarkers.

Bexotegrast at 320 mg demonstrated a statistically significant mean increase in FVC from baseline at all timepoints, surpassing all lower dose cohorts, and showed a strong treatment effect on FVC percent predicted (FVCpp), QLF and profibrotic biomarkers versus placebo at 12 weeks.

The INTEGRIS-IPF Phase 2a trial is evaluating bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 119 patients with idiopathic pulmonary fibrosis.

According to the company, the 320 mg group enrolled 21 patients in the active arm and 8 patients in the placebo arm. Comparable to the lower dose groups, approximately 80% of all enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone. The 320 mg group will continue until all patients have been treated for at least 24 weeks, with final data expected in the second quarter of 2023.

The company noted that Bexotegrast was well tolerated at 320 mg over 12 weeks of treatment with no drug-related severe or serious adverse events (SAEs) reported. All drug-related adverse events were mild or moderate in severity.

Bexotegrast exhibited dose-proportional increases in plasma concentrations, consistent with prior studies.

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