Bexotegrast was well tolerated for up to 40 weeks of treatment without drug-related serious adverse events

Combining bexotegrast with standard treatment reduced FVC decline by 80% relative to standard of care at week 24 alone

89% of bexotegrast-treated patients with an increase in FVC from baseline at week 12 maintained an increase at week 24

Stabilization of fibrosis measured by QLF imaging was observed in the bexotegrast group while the placebo group showed fibrosis progression at weeks 12 and 24

A reduction in patient-reported cough severity was reported in the bexotegrast group in contrast to a worsening in the placebo group

Phase 2b BEACON-IPF trial is expected to initiate in mid-2023

The Company will host a webcast and conference call tomorrow, Monday, May 1st^St at 8:00 p.m. ET

SOUTH SAN FRANCISCO, Calif., April 30, 2023 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. PLRX today announced 24-week data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled, dose-ranging Phase 2a clinical study of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF) . The 320 mg dose group met its primary and secondary endpoints, showing that bexotegrast was well tolerated up to 40 weeks and had a favorable pharmacokinetic profile. The study’s exploratory efficacy endpoints assessed changes in forced vital capacity (FVC), quantitative imaging of pulmonary fibrosis (QLF), patient-reported cough severity, and biomarkers. At week 24, bexotegrast-treated patients demonstrated improvements in all of these exploratory efficacy endpoints compared to placebo.

The phase 2a INTEGRIS-IPF study was designed to evaluate bexotegrast at doses of 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks and 320 mg or placebo for up to 48 weeks in 119 patients with IPF.

The 320 mg group included 21 patients in the active arm and 8 patients in the placebo arm. About 80% of the included patients were comparable to the lower dose groups…