Pliant Therapeutics (PLRX, Financials) shares tumbled 58.8% to $3.21 as of 12:40 p.m. ET on Monday, following a 34.8% decline on Friday, after the company announced a voluntary pause in enrollment and dosing for its BEACON-IPF Phase 2b trial.
The independent Data Safety Monitoring Board of the trial is cited as the reason for the choice.
The suspension, according to the business, will provide time for data assessment and DSMB justification understanding. The study will remain blinded in order to maintain its integrity; patients already enrolled in it will stay in the experiment. Pliant is now alerting worldwide regulatory authorities and has alerted clinical trial investigators.
Targeting ?v?6 and ?v?1 integrins, proteins linked in fibrosis, Bexotegrast is an oral small-molecule inhibitor being studied. The U.S. Food and Drug Administration has assigned it Fast Track and Orphan Drug designations; the European Medicines Agency has assigned it Orphan Drug status. The BEACON-IPF study is assessing the medication as a possible therapy for the progressive lung illness known as idiopathic pulmonary fibrosis, for which there are few therapeutic choices.
Pliant said it is still dedicated to working with authorities and the DSMB to decide the best course ahead, but it did not provide a restarting enrollment timetable. As additional data becomes available, the business said it would provide updates.
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