Pliant Therapeutics Initiates Phase 1 Clinical Study of PLN-74809
January 3, 2019
Development in Orphan Lung Disease Idiopathic Pulmonary Fibrosis Planned
SOUTH SAN FRANCISCO, CA — January 3, 2019 — Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced that it has dosed the first cohort of subjects in a Phase 1 clinical study evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of anti- fibrotic agent PLN-74809.
“Based on positive preclinical studies, and shortly after submitting our first investigational new drug application, Pliant’s first-in-human trial for PLN-74809 is underway and will inform further development of our novel, proprietary compound for the potential treatment of patients with idiopathic pulmonary fibrosis, a disease with very poor prognosis and few impactful treatment options,” said Éric Lefebvre, M.D., chief medical officer of Pliant Therapeutics. “This study’s results will also guide our development plans to evaluate PLN-74809 in other serious diseases where integrins are key drivers of fibrosis by activating TGF-β, including primary sclerosing cholangitis.”
This randomized, double-blind, placebo-controlled, single and multiple ascending oral dose study will enroll approximately 90 healthy participants. The primary objective is the assessment of the safety and tolerability to PLN-74809 after a single dose and following 14 days of dosing. The study also includes evaluation of pharmacokinetics and exploratory assessments of biomarkers related to the activity of the αVβ6 and αVβ1 integrins, the target of PLN-74809 treatment.
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