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Pliant Therapeutics Announces Positive Long-Term Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast was Well Tolerated at 320 mg with Durable Improvement Shown in FVC and Across Multiple Measures
Bexotegrast was well tolerated up to 40 weeks of treatment with no drug-related serious adverse events Combination of bexotegrast with standard of care
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"Bexotegrast was well tolerated up to 40 weeks of treatment with no drug-related serious adverse events Combination of bexotegrast with standard of care reduced FVC decline by 80% relative to standard of care alone at Week 24 89% of bexotegrast-treated patients with an increase in FVC from baseline at Week 12 maintained an increase at Week 24 Stabilization of fibrosis as measured by QLF imaging was observed in the bexotegrast group while the placebo group showed progression of fibrosis at Weeks 12 and 24 A reduction in patient-reported cough severity was reported in the bexotegrast group in contrast to worsening in the placebo group BEACON-IPF Phase 2b trial to be initiated in mid-2023 Company to host webcast and conference call tomorrow, Monday, May 1st at 8:00 a.m. ET SOUTH SAN FRANCISCO, Calif., April 30, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today 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 (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). 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 (FVC), Quantitative Lung Fibrosis (QLF) 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. Bexotegrast 320 mg was Well Tolerated up to Week 40 with No Drug-Related Serious Adverse Events 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 treatmen...