Pliant Therapeutics (PLRX), on Thursday, announced next steps following a recommendation from the Data Safety Monitoring Board or DSMB to pause enrollment and dosing in the BEACON-IPF Phase 2b clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis or IPF.
The company has initiated the assembly of an expert panel, consisting of renowned pulmonary disease and biostatistics specialists, to review unblinded data from the trial and provide an independent recommendation regarding its future direction.
This decision comes after Pliant was unable to determine the rationale for the DSMB's recommendation through blinded data review.
Pliant remains committed to maintaining the integrity of the BEACON-IPF trial, ensuring its potential to serve as a registrational trial.
The expert panel's review process is expected to conclude within two to four weeks.
Bexotegrast has received Fast Track and Orphan Drug Designations from the FDA for IPF.
Currently, PLRX is trading at $3.42 up by 26.10%.
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