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Pliant Therapeutics Announces Initiation of BEACON-IPF, a Phase 2b Clinical Trial of Bexotegrast in Idiopathic Pulmonary Fibrosis
Follows positive data from INTEGRIS-IPF Phase 2a trial SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq:
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"Follows positive data from INTEGRIS-IPF Phase 2a trial\nSOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the initiation of BEACON-IPF, a Phase 2b clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). Bexotegrast is an oral, small molecule, dual-selective inhibitor of αvβ6 and αvβ1 integrins in clinical development for the treatment of IPF and primary sclerosing cholangitis (PSC). “IPF remains an area of great unmet need. With the start of BEACON-IPF, we are achieving an important company milestone and taking a step forward to potentially bringing this novel drug candidate to patients,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “BEACON-IPF follows the positive results from our Phase 2a INTEGRIS-IPF trial demonstrating bexotegrast was well tolerated and demonstrated encouraging preliminary patient benefits for those both on and off current background therapies. We look forward to advancing this trial to further our understanding of bexotegrast as a potential therapy in the treatment of IPF.” BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2b trial evaluating bexotegrast at doses of 160 mg or 320 mg. The trial is planning to enroll approximately 270 patients with IPF at sites globally. The primary endpoint of BEACON-IPF is the assessment of the change from baseline in absolute forced vital capacity (FVC) mL at Week 52. Secondary endpoints include the measurement of time to disease progression (≥10% absolute decline from baseline in FVC precent predicted (FVCpp), respiratory-related hospitalization, or all-cause mortality), change from baseline in absolute FVC (mL) on or not on background therapies, change from baseline in patient reported measurements of symptoms, well-being at Week 52 and safety and tolerability. About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive, fibrosing lung disease of unknown cause with few treatment options and a poor prognosis. Patients experience debilitating symptoms, including shortness of breath and difficulty performing daily activities, such as walking and talking. Currently, ...