SOUTH SAN FRANCISCO, Calif., July 21, 2022 (GLOBE NEWSWIRE) — Pliant Therapeutics (NASDAQ: PLRX) announced today that PLN-74809, its oral, dual-selective αvß6 / αvß1 integrin inhibitor, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of primary sclerosing cholangitis (PSC). PLN-74809, the Company’s lead drug candidate, is currently being tested as part of the INTEGRIS-PSC Phase 2a clinical trial (NCT04480840). Pliant anticipates topline data from this randomized, double-blind, placebo-controlled trial in patients with PSC, in the first half of 2023.
“Fast Track designation in primary sclerosing cholangitis represents a significant milestone in PLN-74809’s development,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “PSC is a deadly disease with no FDA-approved Therapies. Fast Track designation underscores the urgent need for new therapeutic options to address PSC and other fibrotic diseases.”
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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