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PLIANT Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2021 Financial Results August 9 , 2021 - SAD cohorts up to 640 mg and MAD cohorts up to 320 mg completed in extended Phase 1a trial of PLN - 74809 in healthy volunteers with no safety concerns identified - PLN - 74809 Phase 2a 12 - week trials in IPF and PSC currently on track to complete enrollment by the end of 2021 and first half of 2022 , respectively - Analysis of PLN - 74809 Phase 2a PET images underway , including a 320 mg cohort , with preliminary data anticipated upon analysis completion SOUTH SAN FRANCISCO , Calif . , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) -- Pliant Therapeutics , Inc. ( Nasdaq : PLRX ) ( " the Company " ) , a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis , today provided a corporate update and reported second quarter 2021 financial results . " Driven by our progress throughout the second quarter , enrollment continues to be on track for our Phase 2a trials of PLN - 74809 in IPF and PSC with strong advancement in our development stage oncology and DMD programs , " said Bernard Coulie , M.D. , Ph.D. , President and Chief Executive Officer of Pliant Therapeutics . " PLN - 74809 continues to demonstrate a favorable safety profile as additional dose cohorts from the single and multiple ascending dose Phase 1a trial show PLN - 74809 to be generally well tolerated at all dose levels tested , with a predictable pharmacokinetic profile similar to previous dose cohorts . " Second Quarter and Recent Highlights • Single ascending dose ( SAD ) cohorts up to 640 mg and multiple ascending dose ( MAD ) cohorts up to 320 mg completed in extended Phase 1a dose escalation trial of PLN - 74809 in healthy volunteers . PLN - 74809 has completed dosing of additional SAD cohorts of up to 640 mg and MAD cohorts of up to 320 mg once daily dose in an extended dose escalation trial . The pharmacokinetic profile remains generally dose proportional with PLN - 74809 continuing to be generally well tolerated , with no severe adverse events or serious adverse events reported . ● • Enrollment on track for PLN - 74809 Phase 2a trial in idiopathic pulmonary fibrosis ( IPF ) . INTEGRIS - IPF is a 12 - week randomized , dose - ranging , double - blind , placebo - controlled trial evaluating the safety , tolerability , and pharmacokinetics of PLN - 74809 in IPF patients . This trial is evaluating exploratory endpoints including quantitative lung fibrosis score , or QLF , imaging as well as pulmonary function tests . Enrollment is currently on track to be completed by the end of 2021 . • Enrollment on track for PLN - 74809 Phase 2a trial in primary sclerosing cholangitis ( PSC ) . INTEGRIS - PSC is a 12 - week randomized , dose - ranging , double - blind , placebo - controlled trial evaluating the safety , tolerability , and pharmacokinetics of PLN - 74809 in PSC patients . The trial is evaluating exploratory endpoints including fibrosis biomarkers such as Pro - C3 and ELF , changes in ALP , and liver imaging . Enrollment is currently on track to be completed in the first half of 2022 . Image analysis from PLN - 74809 Phase 2a positron emission tomography ( PET ) trial underway , including addition of a 320 mg cohort , with preliminary data anticipated upon completion of the analysis . This open - label , dose ranging trial is evaluating target receptor occupancy levels of PLN - 74809 in the lungs of IPF patients across ascending single - dose cohorts , utilizing a PET tracer of the integrin avß6 . The Company recently amended the protocol to increase the maximum dose to 320 mg . In the second quarter , the first patients were dosed in this cohort . • Preclinical stage integrin - based programs continue to progress . The Company's early - stage programs targeting oncology and muscular dystrophies continue to advance toward the clinic . The oncology program is focused on increasing tumor checkpoint sensitivity through small molecule inhibition of avßg . The muscular dystrophy program is focused on improving muscle function through activation of an integrin compensatory mechanism with a monoclonal antibody . • Resources redeployed in support of ongoing PLN - 74809 Phase 2a trials in IPF and PSC . Despite the rise of recently identified COVID - 19 variants , the broad availability of vaccines , as well as the increased and successful measures taken over the past nine months to contain the virus have resulted in a dramatic decrease in the number of severe and critical COVID - 19 patients with acute respiratory distress syndrome ( ARDS ) . Given the declining number of addressable patients , the Company has discontinued enrollment in the PLN - 74809 Phase 2a COVID - 19 - related ARDS trial allowing for resources