Pliant Therapeutics Receives Orphan Designation from the European Medicines Agency for Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis

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[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics (NASDAQ: PLRX) announced today that its lead drug candidate, bexotegrast (PLN-74809), an oral, once daily, dual-selective αvß6/αvß1 integrin inhibitor, has received Orphan Drug Designation from the European Medicines Agency (EMA) for the potential treatment of idiopathic pulmonary fibrosis (IPF). Bexotegrast is currently being tested in the INTEGRIS-IPF Phase 2a clinical trial in IPF. Pliant presented positive data from the first three dose cohorts of this randomized, double-blind, placebo-controlled trial in July and anticipates topline 12-week data from the 320 mg cohort of patients with IPF, in the first quarter of 2023. “Following the positive interim results from our Phase 2a trial of bexotegrast, we are pleased to receive the EMA's orphan medicinal product designation,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “This designation acknowledges the unmet need in IPF, as well as the potential of bexotegrast, and represents an important milestone in the clinical development of this novel drug. We look forward to continuing our work with the EMA and regulators around the globe to advance this therapy for patients in need.” Orphan Medical Product Designation, granted by the EMA Committee, is designed to encourage the development of new treatments for rare conditions. To qualify, an investigational medicine must target a seriously debilitating or life-threatening condition affecting fewer than five in 10,000 people in the European Union (EU) and must show sufficient non-clinical or clinical data to suggest it may produce clinically relevant outcomes. Benefits of the EMA’s Orphan Drug Designation include trial design assistance, a centralized EU approval process, and 10 years of market exclusivity. Bexotegrast received Orphan Drug Designation from the United States Food and Drug Administration (FDA) in 2018. Background on Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive, fibrosing lung disease of unknown cause with few treatment options and a poor prognosis. Patients experience debilitating symptoms, including shortness of breath and difficulty performing daily activities, such as walking and talking. Currently, there is no pharmacological cure for IPF with neither of the approved two therapies demonstrating a...

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