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Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results
BEACON-IPF pivotal, adaptive Phase 2b/3 trial design implementation significantly accelerates bexotegrast development in IPF Data from completed 12 week Phase
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"BEACON-IPF pivotal, adaptive Phase 2b/3 trial design implementation significantly accelerates bexotegrast development in IPF Data from completed 12 week Phase 2a imaging trial measuring bexotegrast’s effect on total lung collagen and FVC in IPF patients expected in the coming weeksRegulatory clearance for muscular dystrophy program PLN-101325 received, allowing conduct of a first-in-human Phase 1 clinical study SOUTH SAN FRANCISCO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage clinical biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported first quarter 2024 financial results. “In the first quarter, we made significant progress across our portfolio, highlighted by the positive safety and exploratory efficacy data from our Phase 2a INTEGRIS-PSC trial, as well as completion of a Phase 2a PET imaging trial evaluating bexotegrast’s effects on total lung collagen and lung function in IPF patients,\" said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. “Our strong execution has also allowed us to accelerate the ongoing BEACON-IPF Phase 2b trial through the implementation of an adaptive Phase 2b/3 design which will reduce the time to Phase 3 data by up to two years.” First Quarter and Recent Highlights Bexotegrast Highlights Acceleration of bexotegrast development plan with implementation of BEACON-IPF as a pivotal, adaptive Phase 2b/3 trial in patients with idiopathic pulmonary fibrosis (IPF). The adaptive design implementation, based on acceptance by the European Union (EU) and other global health authorities, is expected to significantly shorten bexotegrast’s late-stage development compared to standalone Phase 2b and Phase 3 trials. As part of the adaptive Phase 2b/3 implementation, the Phase 2b portion of BEACON-IPF was upsized from 267 patients to 360 patients. Enrollment is progressing and we expect to complete enrollment of the upsized Phase 2b study expected in the first quarter of 2025.Completion of a 12 week Phase 2a PET imaging trial, measuring the effects of bexotegrast on total lung collagen and forced vital capacity (FVC) in IPF patients. This randomized, double-blind, placebo-controlled trial (NCT05621252) was c...