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Pliant Therapeutics Announces Accelerated Bexotegrast Development Plan for the Treatment of Idiopathic Pulmonary Fibrosis
Acceptance by European Union and other global health authorities of the pivotal, adaptivePhase 2b/3 trial will significantly shorten bexotegrast’s time to
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"Acceptance by European Union and other global health authorities of the pivotal, adaptivePhase 2b/3 trial will significantly shorten bexotegrast’s time to Phase 3 data Upsized Oxford Finance debt facility extends cash runway and funds accelerated development through 2026 SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced the 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, will significantly shorten bexotegrast’s late-stage development compared to a traditional Phase 3 trial. Bexotegrast is an oral, small molecule, dual-selective inhibitor of αvβ6 and αvβ1 integrins in clinical development for the treatment of IPF and primary sclerosing cholangitis (PSC). “The implementation of BEACON-IPF as an accelerated pivotal, adaptive Phase 2b/3 trial design is another example of our efficient approach to drug development,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. “With this trial design, we could shorten the time to Phase 3 data meaningfully.” Following acceptance by the EU and various other global health authorities, the Company is implementing BEACON-IPF as a Phase 2b/3 operationally seamless, adaptive design which includes the ongoing BEACON-IPF Phase 2b trial. Patients will begin enrolling in the Phase 3 component immediately after completion of enrollment of the Phase 2b component of the trial. Because of the seamless design, the power of the Phase 2b will be increased by augmenting the sample size by 90 patients, allowing both components to support potential registration. This increase is expected to have minimal impact on timelines. The Company also announced an amendment to its May 2022 $100 million loan facility with Oxford Finance LLC, upsizing the facility to a total size of $150 million of available non-dilutive capital. This facility, along with the Company’s December 31, 2023 cash and cash equivalents of $495.7 million are expected to fund Pliant through 2026. About Pl...