Pliant gets safety panel nod to test higher dose of bexotegrast in liver disease trial

Pliant Therapeutics (NASDAQ:PLRX) received an independent Data Safety Monitoring Board's (DSMB) greenlight to evaluate a higher dose of its drug bexotegrast.

The company said enrollment began in a phase 2a trial of bexotegrast at 320 mg once daily for at least 24 weeks and up to 48 weeks in patients with primary sclerosing cholangitis (PSC), after a positive safety review from the DSMB.

PSC a chronic liver disease in which the bile ducts become inflamed and scarred, later turning narrow or getting blocked. This leads to build up of bile in the liver causing even more liver damage.

The company said that the DSMB recommended continuation of the study, dubbed INTEGRIS-PSC, without modifications after completion of enrollment of the 40, 80 and 160 mg dose groups.

The DSMB reviewed safety data from all patients enrolled in the trial to date giving a positive review for starting enrollment in the 320 mg dose group, Pliant noted.

"We are pleased to see the continued favorable safety and tolerability profile exhibited by bexotegrast, allowing us to evaluate a higher dose at a longer treatment duration in patients with PSC," said Pliant's Chief Medical Officer Éric Lefebvre.

The company added that the oral drug bexotegrast is being developed to treat PSC and idiopathic pulmonary fibrosis (IPF).