Pharma Focus Europe

Pliant Therapeutics Introduces the BEACON-IPF Phase 2b Clinical Trial to Evaluate Bexotegrast's Potential in Treating Idiopathic Pulmonary Fibrosis

Thursday, August 10, 2023

Pliant Therapeutics, Inc., a biotechnology company listed on Nasdaq under the symbol PLRX, has announced the initiation of a Phase 2b clinical trial named BEACON-IPF. This trial aims to evaluate the efficacy of bexotegrast, a small molecule oral drug developed by the company, in patients suffering from idiopathic pulmonary fibrosis (IPF). Bexotegrast is designed to inhibit both αvβ6 and αvβ1 integrins and is being explored for its potential to treat IPF as well as primary sclerosing cholangitis (PSC).

Dr. Éric Lefebvre, the Chief Medical Officer at Pliant Therapeutics, expressed the company's commitment to addressing the significant unmet medical needs in the field of IPF treatment. He stated that the initiation of the BEACON-IPF trial represents a noteworthy milestone, potentially bringing a new therapeutic option closer to patients. The encouraging outcomes from the Phase 2a INTEGRIS-IPF trial, where bexotegrast exhibited positive effects in patients with or without existing background therapies, provide a basis for further exploration of the drug's potential efficacy in IPF management.

The BEACON-IPF trial, which is set to span 52 weeks, is designed as a randomized, double-blind, placebo-controlled study and will be conducted across multiple countries. Bexotegrast will be administered at two dosage levels, 160 mg and 320 mg, with approximately 270 IPF patients participating globally. The primary endpoint of the trial is the assessment of absolute forced vital capacity (FVC) mL change from baseline at Week 52. The study will also evaluate secondary endpoints such as the time to disease progression (defined by a ≥10% absolute decline from baseline in FVC percent predicted, respiratory-related hospitalization, or all-cause mortality), changes in absolute FVC (mL) in patients on or off background therapies, alterations in patient-reported symptom measurements and well-being at Week 52, as well as safety and tolerability.

Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive lung disease with an unknown cause, limited treatment options, and a poor prognosis. IPF patients experience debilitating symptoms that significantly affect their daily lives. The currently approved therapies for IPF only provide limited relief and do not halt the disease's progression. This underscores the critical need for innovative treatments to address both the symptoms and the underlying disease progression in patients suffering from this condition.

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