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Intercept Announces New OCA Data in PBC and NASH to be Presented at EASL 2016


Intercept Pharmaceuticals, Inc. ICPT, +0.00% a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, announced today that multiple abstracts evaluating obeticholic acid (OCA) in patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), and nonalcoholic steatohepatitis (NASH) will be presented at the International Liver Congress 2016, the 51st Annual Meeting of the European Association for the Study of the Liver (EASL), in Barcelona, Spain, from April 13-17, 2016.

Intercept will present eight abstracts at the Congress, including new analyses of the Phase 3 POISE trial in PBC and Phase 2 FLINT trial in NASH. Study designs for the Phase 3 REGENERATE Trial in NASH and Phase 2 CARE trial in biliary atresia will also be presented.

"It is exciting to see the new emphasis on non-viral liver disease at research forums like the International Liver Congress," said David Shapiro, M.D., Intercept's Chief Medical Officer & Executive Vice President, Development. "As we continue to prepare for potential U.S. and European approvals of OCA for patients with primary biliary cholangitis this year, cholestatic liver diseases like PBC and PSC are receiving more attention from researchers and clinicians. Additionally, new analyses of the FLINT trial continue to provide the hepatology community with important insights about NASH, a condition which is continuing to grow into a global public health issue in liver disease."

In addition to the clinical study presentations and posters, two of Intercept's collaborators will be giving oral presentations on the role of nuclear receptors in metabolism and cancer and the gut liver axis. Intercept will continue to explore this area with a recently announced research collaboration to evaluate the effects of OCA and other product candidates on the microbiome in a variety of non-viral liver diseases, beginning with NASH.

Intercept will be exhibiting at booth #1200 throughout the meeting. Presentations at the International Liver Congress include:

Oral Presentation

Saturday, April 16, 12:30 - 12:45, Hall 8.0-A1
"Predictors of Improvement in NAFLD Activity Score on Placebo: a Secondary Analysis of the FLINT Trial" (Abstract PS109)
Rohit Loomba, Arun J. Sanyal, Kris V. Kowdley, Norah Terrault, Naga Chalasani, Manal F. Abdelmalek, Arthur J. McCullough, Beatrice Ferguson, Lois Lee, Reshma Shringarpure, David Shapiro, Brent A. Neuschwander-Tetri

Basic Science Seminar - Gut-Liver Axis

Wednesday, April 13, 15:00 - 15:30, Hall 8.1-A1
"Tissue-Specific Actions of Nuclear Receptors in Metabolism and Cancer"
Antonio Moschetta, Marica C. Cariello

Thursday, April 14, 08:30 - 09:00, Hall 8.1-A1
"Identification of the Gut Vascular Barrier Linking the Gut with the Liver"
Maria Rescigno, Ilaria Spadoni

Poster Presentations in PBC

Friday, April 15, 08:00 - 18:00, Hall 8.1
"Exposure-Response Relationship of Obeticholic Acid for Alkaline Phosphatase and Total Bilirubin in Patients with Primary Biliary Cirrhosis/Cholangitis" (Abstract FRI-394)
Jeffrey E. Edwards, Carl LaCerte, Leng Hong Pheng, Thomas...