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Intercept To Present New NASH And PBC Data At The Digital International Liver Congress 2020

New analyses of the interim analysis data from the Phase 3 REGENERATE study describe the benefit of obeticholic acid (OCA) on noninvasive measures of liver fibrosis in NASH patients on treatment for at least 24

Benzinga · 08/21/2020 12:01

New analyses of the interim analysis data from the Phase 3 REGENERATE study describe the benefit of obeticholic acid (OCA) on noninvasive measures of liver fibrosis in NASH patients on treatment for at least 24 months
 

Additional long-term data in PBC highlight the safety and durable efficacy of OCA through six years of open label treatment

NEW YORK, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that multiple abstracts regarding the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) with OCA will be presented at the Digital International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL), to be held virtually from August 27, 2020 to August 29, 2020.

"The new data to be presented at this year's International Liver Congress add to the already substantial body of evidence supporting the anti-fibrotic efficacy of OCA in patients with advanced fibrosis due to NASH," said Mark Pruzanski, M.D., President and CEO of Intercept. "We are also excited to see that several Ocaliva® PBC abstracts that deepen the understanding of our drug's long-term safety and efficacy profile will be presented, including one presenting the six-year data from the open label extension of our Phase 3 POISE trial. On behalf of all my colleagues at Intercept, I'd like to thank EASL for providing this virtual forum for important new hepatology research and scientific exchange during the COVID-19 pandemic."

Presentations at the Digital International Liver Congress include:

Late-Breaker Poster Presentation

"Obeticholic acid demonstrates sustained improvements at month 24 in transaminases and non-invasive markers of fibrosis: results of a post hoc analysis from the interim analysis of the REGENERATE study" (LBP19)

Rohit Loomba, Vlad Ratziu, Quentin M. Anstee, Stephen Harrison, Arun Sanyal, Mary Rinella, Zobair Younossi, Zachary Goodman, Pierre Bedossa, Reshma Shringarpure, Huafeng Zhou, Aditya Venugopal, Mazen Noureddin

Oral Presentation

"Obeticholic acid (OCA) improves experimental non-invasive markers of NASH and advanced fibrosis: results of a secondary analysis from the month-18 interim analysis of the REGENERATE study" (AS075)

Jerome Boursier, Rohit Loomba, Quentin M. Anstee, Stephen Harrison, Arun Sanyal, Mary Rinella, Zobair Younossi, Zachary Goodman, Pierre Bedossa, Céline Fournier, Michael Stenkilsson, Reshma Shringarpure, Luna Zaru, Aditya Venugopal, Leigh MacConell, Vlad Ratziu

General Poster Presentations

"The burden of disease associated with non-alcoholic steatohepatitis patients under standard of care" (THU048)

Raluca Pais, William Green, Stuart Mealing, Aldo Trylesinski, Sandrine Cure, Heather Davies

"Predicted risk of end stage liver disease utilizing the UK-PBC risk score with continued standard of care and subsequent addition of obeticholic acid for 60 Months in patients with primary biliary cholangitis" (THU114)

David E. Jones, Marco Carbone, George Mells, Alexander Liberman, Elizabeth Smoot Malecha, Leigh MacConell

"Noninvasive tests for assessing fibrosis in patients with non-alcoholic fatty liver disease: an evaluation of combining test results" (FRI009)

Catherine Vick, Andrew Joyce, Amy Law, Molly Sherwood, Essy Mozaffari, Bruce Wong

"Obeticholic acid improves hepatic fibroinflammation as assessed by multiparametric magnetic resonance imaging: interim results of the REGENERATE trial" (FRI066)

Rohit Loomba, Quentin M. Anstee, Stephen Harrison, Arun Sanyal, Vlad Ratziu, Zobair Younossi, Zachary Goodman, Pierre Bedossa, Rajarshi Banerjee, Michael Stenkilsson, Reshma Shringarpure, Luna Zaru, Aditya Venugopal, Leigh MacConell, Mary Rinella

"Obesity-specific health-related quality of life in patients with non-alcoholic steatohepatitis: results from the REGENERATE study" (FRI080)

Zobair Younossi, Maria Stepanova, Fatema Nader, Rohit Loomba, Quentin M. Anstee, Vlad Ratziu, Stephen Harrison, Arun Sanyal, Jacob George, Susanne Beckebaum, David Orr, Giuseppe Mazzella, Victor Vargas, Lise Lotte Gluud, Rifaat Safadi, James Trotter, Jaideep Behari, David Sheridan, Muhammad Y. Sheikh, Martin Bonacci, Gail Cawkwell, Bruce Wong, Pierre Bedossa, Zachary Goodman, Mary Rinella, on behalf of the REGENERATE Study Investigators

"Durability of biochemical improvements through six years of open label treatment with obeticholic acid in patients with primary biliary cholangitis who did not achieve the POISE criteria" (FRI146)

Gideon M. Hirschfield, Marco Carbone, David E. Jones, Bettina E. Hansen, Andreas E. Kremer, Michael Trauner, Alexander Liberman, Elizabeth Smoot Malecha, Leigh MacConell

"Efficacyand tolerance of obeticholic acid in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid in real life: interim analysis of the OCARELIFE study" (FRI180)

Vincent Leroy, Christophe Corpechot, Jérôme Dumortier, Laurent Alric, Dominique Larrey, Sébastien Dharancy, Olivier Chazouilleres, Alexandra Heurgue, François Boer, Aldo Trylesinski

A full list of sessions at the Digital International Liver Congress™ 2020 is available at https://ilc-congress.eu.