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Pliant Therapeutics Announces Positive Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast 320 mg was Well Tolerated and Achieved Statistically Significant FVC Increase in Patients with Idiopathic Pulmonary Fibrosis
Bexotegrast demonstrated statistically significant increase in FVC at 4, 8 and 12 weeks of treatment, outperforming lower dose groups No bexotegrast-treated
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"Bexotegrast demonstrated statistically significant increase in FVC at 4, 8 and 12 weeks of treatment, outperforming lower dose groups No bexotegrast-treated patients experienced disease progression as defined by FVCpp decline of greater than or equal to 10% Bexotegrast was well tolerated over 12 weeks of treatment with no drug-related severe or serious adverse events Company to host webcast and conference call tomorrow, Monday, January 23rd at 8:00 a.m. ET SOUTH SAN FRANCISCO, Calif., Jan. 22, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced 12-week interim data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). 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 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 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 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. Bexotegrast 320 mg was Well Tolerated with No Drug-Related Severe or Serious Adverse Events The primary endpoint of the INTEGRIS-IPF trial is the evaluation of the safety and tolerability of bexotegrast. The secondary endpoint is an assessment of its pharmacokinetics. Bexotegrast was well tolerated at 320 mg over 12 weeks of treatment with no drug-related severe or ...