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Pliant Therapeutics Announces Positive DSMB Safety Review and Initiation of Enrollment of Phase 2a Trial of Bexotegrast (PLN-74809) at 320 mg Dose in Primary Sclerosing Cholangitis
Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-PSC Phase 2a trial continue without modification and proceed to
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-PSC Phase 2a trial continue without modification and proceed to evaluate 320 mg dose\nSOUTH SAN FRANCISCO, Calif., March 13, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today 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 αvβ6 and αvβ1 integrins being developed for the treatment of PSC and idiopathic pulmonary fibrosis (IPF). Bexotegrast has been administered to over 600 study participants to date, including healthy volunteers and patients, with no drug-related severe or serious adverse events reported to date. “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 Éric Lefebvre M.D. Chief Medical Officer of Pliant Therapeutics. “We recognize the high unmet medical need in PSC, as there are no FDA approved therapies for the indication and look forward to sharing 12-week interim data from our Phase 2a trial in the third quarter.” DSMB Recommends Continuation of INTEGRIS-PSC Phase 2a Trial Without ModificationsFollowing 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. About the INTEGRIS-PSC Phase 2a TrialThis Phase 2a trial is a randomized, double-blind, dose-ranging, placebo-controlled study evaluating bexotegrast at doses ranging from 40 to 320 mg, administered daily in approximately 112 patients with PSC. The initiation of the 320 mg dose group coincides with the FDA authorization to evaluate long-term dosing of bex...