Pliant Therapeutics, Inc. announced that, following a positive independent Data Safety Monitoring Board (DSMB) safety review, enrollment has commenced in a Phase 2a trial of bexotegrast at 320 mg dosed once daily for at least 24 weeks and up to 48 weeks in patients with primary sclerosing cholangitis (PSC). Bexotegrast, is an oral, small molecule, dual-selective inhibitor of v6 and v1 integrins being developed for the treatment of PSC and idiopathic pulmonary fibrosis (IPF). Following the completion of enrollment of the 40, 80 and 160 mg dose groups in the INTEGRIS-PSC Phase 2a trial, a meeting of the bexotegrast independent DSMB was held earlier this month to review safety data from all patients enrolled in the trial to date.

The DSMB recommended that the INTEGRIS-PSC trial continue without modification, enabling the initiation of enrollment of the 320 mg dose group.