Pliant Therapeutics (Nasdaq: PLRX), a Californian biopharma focused on discovering and developing fibrosis drugs, saw its shares close down 35% on Friday, and plunge a further 58% to $3.27 in after-hours trading after it announced a setback for its lead candidate, bexotegrast.
Pliant said that, following a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board (DSMB), the company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase IIb trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). Patients currently enrolled in BEACON-IPF will remain in the trial.
Enrollment and dosing have been paused while data is reviewed to understand the DSMB’s rationale for their recommendation. Blinding of the study will be maintained to preserve trial integrity. The company has informed BEACON-IPF clinical trial investigators and is in the process of informing global regulatory authorities.
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