SOUTH SAN FRANCISCO — October 23, 2019 — Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced it has entered into a strategic collaboration and license agreement with Novartis covering the development and commercialization of Pliant’s preclinical product candidate, PLN-1474 and up to three additional integrin targets. PLN-1474 is an internally discovered small molecule selective inhibitor of integrin αVβ1, currently being developed for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis (NASH).
“Our research continues to generate compelling preclinical evidence that supports the advancement of PLN-1474 as a clinical candidate and validates our approach of evaluating αVβ1 integrin inhibition to treat advanced liver fibrosis associated with NASH,” said Bernard Coulie, M.D., Ph.D., president and chief executive officer of Pliant Therapeutics. “Pairing Pliant’s leading integrin biology and drug discovery capabilities with Novartis, a world-leader with one of the broadest pipelines investigating mono and combination therapies for liver diseases including NASH, will support our goal of developing novel therapies for fibrotic diseases and potentially bring meaningful treatment options to patients.”
Pliant will initially receive $80 million from Novartis, including an upfront payment in connection with the collaboration agreement as well as equity investment commitments. The collaboration agreement is for a worldwide exclusive license to PLN-1474 and up to three additional product candidates generated under the collaboration. In addition, Novartis will fund Pliant’s research and development activities under the collaboration. Pliant will be responsible for development of PLN-1474 through Phase 1 after which Novartis will assume responsibility for all future development, manufacturing and commercialization. Pliant is eligible to earn milestone payments, contingent upon the achievement of specified development, regulatory and commercial milestones. The agreement also provides for tiered royalties payable to Pliant ranging from the mid-single digits to low double digits on product sales upon commercialization. The transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
NASH associated cirrhosis is the fastest growing indication for liver transplantation in the United States. Many patients with NASH develop associated liver fibrosis, which can lead to complications such as cirrhosis and ultimately liver failure. While several investigational agents target mechanisms that impact the earlier stages of the NASH continuum, Pliant is targeting αvβ1, an integrin that activates TGF-β, a putative master regulator of hepatic fibrosis. PLN-1474 has shown significant inhibition of fibrosis in live human tissue models. Pliant expects to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration before the end of 2019.
Pliant’s approach focuses on fibrotic tissue-specific inhibition of integrins and the TGF-β pathway. PLN-1474, a small molecule selective inhibitor of the αVβ1 integrin, is currently being evaluated for the treatment of liver fibrosis in NASH. In preclinical studies, PLN-1474 was observed to selectively block the αvβ1 integrin mediated activation of TGF-β, reducing the growth of fibrotic tissue within the liver. PLN-1474 is currently in IND-enabling studies.
About Pliant Therapeutics
Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant seeks to slow or halt the progression of multiple life-threatening fibrotic diseases by developing targeted treatments. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and has completed Phase 1b testing. For more information, please visit www.pliantrx.com.