Pliant Therapeutics announced the successful completion of its first-in-human clinical study of its lead product candidate, PLN-74809. The small molecule inhibitor of the αVβ6 and αVβ1 integrins was shown to be safe and well tolerated in healthy volunteers, and the results support further development in patients with idiopathic pulmonary fibrosis (IPF), a chronic and progressive fibrotic lung disease with few treatment options.
The randomized, double-blind, placebo-controlled study of PLN-74809 clearly demonstrated the small molecule's good oral bioavailability in humans and its dose-proportional pharmacokinetics after a single dose and following 14 days of once-daily administration, at doses ranging from 10 to 75 mg. The compound was well-tolerated across all doses in 71 study participants and its long half-life supports once-daily dosing.
"Less than six months after initiating our first-in-human study evaluating PLN-74809, we're pleased to report that the compound has a favorable safety, tolerability and pharmacokinetic profile, which warrants advancing it to the next stage of development," said Éric Lefebvre, M.D., chief medical officer of Pliant Therapeutics. "We are now progressing with Phase 1b evaluation of PLN-74809 to assess its effects on TGF-β activation in alveolar macrophages collected from healthy volunteers and plan to initiate our Phase 2a program in IPF patients in the second half of 2019."
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