Pliant Therapeutics Initiates Outside Expert Panel to Review BEACON-IPF Trial Data

Pliant Therapeutics, Inc. (NASDAQ: PLRX) recently disclosed the initiation of a pivotal move in response to the recommendations of the trial’s independent Data Safety Monitoring Board (DSMB). The company has commenced the assembly of an external expert panel for the review of unblinded data stemming from the ongoing Phase 2b trial on BEACON-IPF, targeted at patients diagnosed with idiopathic pulmonary fibrosis (IPF). This strategic step aligns with the charter laid out for the DSMB of the trial.

As part of this initiative, the expert panel, comprised of renowned individuals specializing in pulmonary diseases and biostatistics, will offer an independent assessment to Pliant with respect to the ongoing BEACON-IPF trial. Post-assessment, the panel will further contribute to an enlarged DSMB, aiming to provide a consolidated recommendation concerning BEACON-IPF. The decision to convene an external panel was made following an inability on the part of the company to deduce the rationale behind the DSMB’s guidance to halt enrollment and dosing in the trial through the review of blinded data. It is anticipated that this process will conclude within a timeframe of two to four weeks.

Subsequent to the prior recommendation made by the DSMB, Pliant voluntarily paused the enrollment and dosing within the BEACON-IPF clinical trial. The company remains committed to sustaining the blinding in order to uphold the integrity of the data within the Phase 2b clinical trial of BEACON-IPF, with the overarching objective of it potentially serving as a registrational trial.

Pliant Therapeutics, Inc., a late-stage biopharmaceutical entity, is spearheading innovations in the realm of fibrotic disease therapeutics. Their lead product candidate, bexotegrast (PLN-74809), a dual-selective inhibitor of αv ß6 and αv ß1 integrins, is in development for the primary indication of treating idiopathic pulmonary fibrosis (IPF). Bexotegrast has garnered Fast Track Designation and Orphan Drug Designation from regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency. The company has kicked off BEACON-IPF, an adaptive Phase 2b/3 trial focusing on bexotegrast for treating IPF. Additionally, Pliant is engaged in a Phase 1 exploration for their third clinical program, PLN-101095, a dual-selective inhibitor of αv ß8 and αv ß1 integrins tailored for solid tumors. Regulatory approval has also been received for a Phase 1 study of PLN-101325, a monoclonal antibody agonist targeting muscular dystrophies.

For more information, visit www.PliantRx.com.

Statements in this press release that delve into matters beyond historical facts are regarded as “forward-looking statements.” Such statements involve outlooks about future events, conditions, or circumstances, subject to risks and uncertainties. The company does not bear the onus to update any of these forward-looking statements post this release.

Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
[email protected]

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Pliant Therapeutics’s 8K filing here.

Pliant Therapeutics Company Profile

Pliant Therapeutics, Inc, a clinical stage biopharmaceutical company, discovers, develops, and commercializes novel therapies for the treatment of fibrosis and related diseases in the United States. The company's lead candidate is bexotegrast, an oral, small-molecule, dual selective inhibitor of avß6 and avß1 integrins, which is in phase 2b trials for idiopathic pulmonary fibrosis and in phase 2a trial for primary sclerosing cholangitis.