Pliant Therapeutics, Inc., a biotechnology company specializing in developing and commercializing treatments for fibrotic diseases, announced on January 3, 2019 through PRNewswire, that it has initiated a Phase 1 first-in-human clinical study of small molecule PLN-74809. The trial/study evaluates the safety, tolerability, pharmaco-dynamics and pharmacokinetics of antifibrotic agent PLN-74809.
About the Study
The study is designed as a randomized, double-blind, placebo-controlled, single and multiple ascending oral dose trial, and will enroll 90 healthy participants. Its primary aim is to assess the safety and tolerability of subjects to PLN-74809 starting at day 1 and continuing for 14 days.
The study is also designed to evaluate pharmacokinetics and biomarkers related to αVβ6 and αVβ1 integrins. PLN-74809 is an oral dual selective inhibitor of the αVβ6 and αVβ1 integrins.
As noted in pre-clinical studies of PLN-74809, Pliant’s therapy puts emphasis on integrins which block activation of TGF-β and thus prevent fibrotic tissue from forming in the lungs.
A Word of Encouragement
“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.
Dr. Lefebvre mentioned that the results of this study will assist in evaluating the effacacy of PLN-74809 in treatment of other diseases where integrins are the key element of fibrosis. As an example Dr. Lefebvre explained that this would include primary sclerosing cholangitis (PSC) which is a chronic progressive disorder of the bile ducts in the liver.
FDA Approval
Pliant announced in August 2018, that the Food and Drug Administration (FDA) granted orphan drug status to PLN-74809 for idiopathic pulmonary fibrosis and primary sclerosing cholangitis. The mission of the FDA Office of Products Development is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
IPF, a rare disease that affects about 140,000 people in the U.S., causes approximately 40,000 deaths every year. PSC, a rare disease of the bile ducts, may eventually lead to liver failure. This disease affects approximately 30,000 people in the U.S.
Primary sclerosing cholangitis (PSC) is a long-term progressive disease of the liver and gallbladder characterized by inflamation and scarring of the bile ducts which normally allow bile to drain from the gallbladder.
About Pliant Therapeutics
PRNewswire’s release of July 16, 2018 outlined a Series B financing whereby Pliant will use the funds to support clinical trials in idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis, as well as ongoing drug discovery programs.
Pliant plans to obtain proof of concept in patients for its lead molecule in 2019.
