Pliant Thera lines up experts to review BEACON-IPF Phase IIb/III trial

California, USA-based fibrosis specialist Pliant Therapeutics (Nasdaq: PLRX) saw its shares leap 20.95% to $3.29 by close of trading Thursday, after it revealed that, per the charter of the trial’s independent Data Safety Monitoring Board (DSMB), it has initiated the assembly of an outside expert panel to review unblinded data from the ongoing BEACON-IPF Phase IIb trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), which was voluntarily paused this week. 

Pliant noted that the panel, consisting of world-renowned experts in pulmonary diseases and biostatistics, will provide an independent recommendation to Pliant regarding the BEACON-IPF trial. Subsequently, the panel will serve as part of an expanded DSMB with the goal to reach a consensus recommendation regarding BEACON-IPF. The decision to assemble the outside panel was taken as the company has not been able, through review of blinded data, to determine the rationale for the DSMB’s recommendation to pause enrollment and dosing in the trial. Pliant expects this process to conclude in two to four weeks.

Following the DSMB’s previously announced recommendation, Pliant voluntarily paused enrollment and dosing in the BEACON-IPF clinical trial. Pliant is committed to remaining blinded ensuring the data integrity of the BEACON-IPF IIb clinical trial with the goal of maintaining its potential to serve as a registrational trial.