Following a prespecified data review and recommendations by the trial’s independent data safety monitoring board, Pliant Therapeutics has voluntarily paused enrollment and dosing in an ongoing phase 2b trial of its lead candidate, bexotegrast, in patients with idiopathic pulmonary fibrosis (IPF).
The San Francisco-based biotech did not give details beyond sharing that enrollment and dosing have been paused “while data is reviewed to understand the DSMB’s rationale for their recommendation.”
Patients currently enrolled in BEACON-IPF trial will remain in the trial and blinding of the study will be maintained to preserve trial integrity.
Bexotegrast is an oral small molecule, dual-selective inhibitor of the αvβ6 and αvβ1 integrins that is in development in the lead indication for the treatment of IPF. The disease is characterized by excessive collagen deposition in the lung that, over time, leads to permanent scarring that makes it progressively more difficult to breathe.
Bexotegrast has Fast Track designation and Orphan Drug designation from the FDA and Orphan Drug designation from the EMA in IPF.