SOUTH SAN FRANCISCO - Pliant Therapeutics, Inc. (NASDAQ: PLRX), a biotechnology firm focused on fibrotic diseases, has announced the progression of its BEACON-IPF trial to a pivotal, adaptive Phase 2b/3 study for its drug candidate bexotegrast, following acceptance by the European Union and other global health authorities. This shift is expected to expedite the development timeline for bexotegrast, an oral treatment for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC).
The company's president and CEO, Bernard Coulie, M.D., Ph.D., emphasized the potential for the adaptive trial design to shorten the time to Phase 3 data. The BEACON-IPF trial will now seamlessly transition from Phase 2b to Phase 3, with immediate enrollment in the latter upon completion of the former. The addition of 90 patients to the Phase 2b sample size is intended to enhance the trial's power without significantly affecting the timeline.
Pliant also disclosed an amendment to its loan agreement with Oxford Finance LLC, increasing its debt facility from $100 million to $150 million. This expansion, coupled with the company's reported cash reserves of $495.7 million as of December 31, 2023, is projected to fund operations through 2026.
Bexotegrast has garnered Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for IPF and PSC, as well as Orphan Drug designation from the European Medicines Agency for the same conditions. In addition to bexotegrast, Pliant is developing other candidates targeting fibrotic diseases, including a Phase 1 study for NASH with liver fibrosis and a preclinical program for muscular dystrophies.
The company's forward-looking statements indicate that the adaptive trial design could significantly accelerate bexotegrast's late-stage development. However, these statements are subject to various risks and uncertainties inherent in drug development, marketplace conditions, and reliance on third parties.
The information provided in this article is based on a press release statement from Pliant Therapeutics.
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