Pliant Therapeutics announces long-term data from INTEGRIS-IPF Phase 2a trial

Pliant Therapeutics announced 24-week data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis. The 320 mg dose group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated up to 40 weeks and displayed a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints assessed changes in forced vital capacity, Quantitative Lung Fibrosis imaging, patient reported cough severity and biomarkers. At Week 24, bexotegrast-treated patients demonstrated improvements across all of these exploratory efficacy endpoints versus placebo. The INTEGRIS-IPF Phase 2a trial was designed to evaluate bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks and 320 mg or placebo for up to 48 weeks in 119 patients with IPF. 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 enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone. The primary endpoint of the INTEGRIS-IPF trial was the evaluation of the safety and tolerability of bexotegrast. Bexotegrast was well tolerated at 320 mg up to 40 weeks of treatment with no drug-related serious adverse events reported. Most frequently reported treatment-emergent adverse events were mild or moderate in severity and not related to study drug. No TEAE-related discontinuations occurred after Week 12. The trial’s secondary endpoint was an assessment of its pharmacokinetics. Bexotegrast exhibited dose-proportional increases in plasma concentrations, consistent with prior dose groups. The exploratory efficacy endpoints of the INTEGRIS-IPF trial measured changes in FVC, high-resolution CT-based QLF, patient reported cough severity and profibrotic biomarkers to Week 24. At Week 24, 50% of bexotegrast-treated patients experienced an increase in FVC from baseline versus 0% in the placebo group. Moreover, of the bexotegrast-treated patients who experienced an increase in FVC from baseline at Week 12, 89% maintained an increase in FVC from baseline at Week 24.