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Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced a late-breaking presentation of results from the INTEGRIS-PSC Phase 2a trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) at The Liver Meeting® 2023 of the American Association for the Study of Liver Diseases (AASLD), in Boston, Massachusetts, November 10 – 14. Bexotegrast is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis (IPF) and PSC.
The oral presentation titled "Oral αvβ6/αVβ1 Integrin Inhibition in Primary Sclerosing Cholangitis: 12-week Interim Safety and Efficacy Analysis of INTEGRIS-PSC, A Phase 2a Trial of Bexotegrast," will be delivered by Professor Gideon Hirschfield, M.D., Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Centre for Liver Disease.
"We are pleased to be sharing these positive interim results from the INTEGRIS-PSC trial with the scientific and medical communities as part of this leading hepatology conference," said Éric Lefebvre, M.D., Chief Medical Officer of Pliant. "Recognizing that no approved treatments are available for patients with PSC, we look forward to the further investigation of bexotegrast including 12 week data from the 320 mg dose in the first quarter of 2024 and 24 week safety data in mid-2024."
Late-Breaking Oral Presentation
Monday, November 13 5:00 PM EST
Oral αvβ6/αVβ1 Integrin Inhibition in Primary Sclerosing Cholangitis: 12-week Interim Safety and Efficacy Analysis of INTEGRIS-PSC, A Phase 2a Trial of Bexotegrast (Abstract #5008)
Gideon M. Hirschfield, Kris V. Kowdley, Michael Trauner, Palak J. Trivedi, Éric A. Lefebvre, Johanna Schaub, Annie Clark, Theresa Thuener, Hardean E. Achneck, Chris N. Barnes, Richard Pencek, Aldo J, Montano-Loza, Christopher L. Bowlus, Christoph Schramm, Cynthia Levy
The late-breaker poster will be made available on the Publications page of the Pliant website at the time of presentation.
Background on Primary Sclerosing Cholangitis
PSC is a rare, progressive liver disease of unknown origin, which frequently occurs in the setting of inflammatory bowel disease. PSC affects more than 30,000 patients in the United States and over 100,000 patients worldwide. The disease can occur in all ages, gender, and race. PSC is characterized by inflammation and fibrosis, with progressive liver and biliary damage leading to cirrhosis and liver failure. Currently there are no FDA or EMA-approved therapies for patients with PSC. Therefore, there is a high unmet need for new therapeutic options to address the symptoms and modify the disease progression of this grievous illness.
INTEGRIS-PSC Multinational Phase 2a Trial of Bexotegrast (NCT04480840)
INTEGRIS-PSC is a Phase 2a, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of bexotegrast administered over 12 weeks in patients with IPF. Patients were enrolled in doses of 40 mg, 80 mg, 160 mg or 320 mg, with a 3:1 randomization ratio (active:placebo) and stratification based on use of ursodeoxycholic acid (UDCA). The primary endpoint is the evaluation of bexotegrast safety and tolerability and the secondary endpoint is the assessment of pharmacokinetics across the range of doses. Exploratory endpoints will measure changes in liver fibrosis markers, ELF and PRO-C3, liver biochemistry and liver imaging.
Posted In: PLRX
