Pliant Therapeutics Receives FDA Fast Track Designation for PLN-74809 for the Treatment of Idiopathic Pulmonary Fibrosis

SOUTH SAN FRANCISCO, Calif., May 03, 2022 (GLOBE NEWSWIRE) — Pliant Therapeutics (NASDAQ: PLRX) announced today that PLN-74809, its oral, dual-selective α_vß₆/α_vß₁ integrin inhibitor, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of idiopathic pulmonary fibrosis (IPF). PLN-74809, the Company’s lead drug candidate, is currently being tested as part of the INTEGRIS-IPF Phase 2a clinical trial (NCT04396756). Pliant anticipates topline data from this randomized, double-blind, placebo-controlled trial in patients with IPF, in mid-2022.

“The Fast Track designation marks an important step in PLN-74809’s clinical development in IPF. It underscores the urgent need for new therapeutic options to address this devastating disease,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “We will continue to work closely with the FDA to support the future development of PLN-74809 beginning with data from the Phase 2a INTEGRIS-IPF trial, which is on track for readout in mid-2022.”

FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. To qualify, available clinical and non-clinical data need to demonstrate the potential to address unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.

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