Monday, November 5, 2018

Liver Meeting® 2018 - Intercept's NASH clinical development program

Intercept Announces New OCA Data to be Presented at The Liver Meeting® 2018

NEW YORK, Nov. 05, 2018 (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 obeticholic acid (OCA) abstracts will be presented at The Liver Meeting® 2018, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 9-13 in San Francisco, California.

“At this year’s Liver Meeting, we look forward to sharing new data from our innovative clinical programs, which further our understanding of treatment approaches aimed at impacting the lives of patients with progressive non-viral liver diseases,” said Christian Weyer, M.D., M.A.S., Intercept's Executive Vice President, Research & Development. “As we approach the read-out from the interim analysis of our Phase 3 REGENERATE trial in the first half of 2019, we are excited to present abstracts that highlight the depth and breadth of our NASH clinical development program.”

Select presentations at The Liver Meeting include:

Oral Presentation:
Sunday, November 11, 2018 – 11:30 a.m. PT
“Obeticholic Acid Was Safe and Well Tolerated in Patients with NASH and Compensated Cirrhosis: A Secondary Analysis of the CONTROL Study” (Abstract #0071)
Dina Halegoua-DeMarzio, Paul Thuluvath, Manal F. Abdelmalek, Courtney Van Biene, Reshma Shringarpure, Leigh MacConell

Poster Presentations:
Sunday, November 11, 2018 – 8 a.m. – 5:30 p.m. PT
“CONTROL: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Patients with Nonalcoholic Steatohepatitis” (Abstract #1672)
Paul J. Pockros, Michael Fuchs, Bradley Freilich, Eugene Schiff, Anita Kohli, Eric J. Lawitz, Paul A. Hellstern, David E. Cohen, Janet Owens-Grillo, Courtney Van Biene, Reshma Shringarpure, Leigh MacConell, David Shapiro

“Efficacy and Safety of Obeticholic Acid in Patients with Nonalcoholic Steatohepatitis and Significant Fibrosis Using Endpoint Definitions and Populations Accepted for Registrational Studies” (Abstract #1673)
Brent A. Neuschwander-Tetri, Kris V. Kowdley, Arun J. Sanyal, Manal F. Abdelmalek, Norah Terrault, Arthur J. McCullough, Peter Wang, Reshma Shringarpure, Leigh MacConell, David A. Shapiro, Rohit Loomba

“Safety, Pharmacokinetics and Pharmacodynamics of Obeticholic Acid in Subjects with Compensated Cirrhosis due to NASH” (Abstract #1709)
Naim Alkhouri, Jeffrey Edwards, Fred Poordad, Eric Lawitz, Lois Lee, Sharon Karan, Jason Campagna, Leigh MacConell

“Beyond Sirius Red: Collagen Isoforms for Quantitative Histological Analysis of Liver Fibrosis in Preclinical Models of Diet-induced and Biopsy-confirmed Nonalcoholic Steatohepatitis” (Abstract #1760)
Thea Johansen, Denise Oró, Sanne S. Veidal, Michael Feigh, Henrik H. Hansen, Niels Vrang, Mark Young, Jacob Jelsing, Jonathan D. Roth

Monday, November 12, 2018 – 8 a.m. – 5:30 p.m. PT
“Hepatic Safety Overview of Obeticholic Acid for the Treatment of Patients with Primary Biliary Cholangitis” (Abstract #1931)
Paul J. Pockros, Mitchell L. Shiffman, Christopher Bowlus, Arun J. Sanyal, Frederik Nevens, Richard Pencek, David Shapiro, Amrik Shah, Leigh MacConell

“PBC Patient Care Pathway” (Abstract #1886)
Gideon M. Hirschfield, Marco Carbone, Helena Cortez-Pinto, Guilherme Macedo, Victor de Lédinghen, Olivier Chazouilleres, Femi Adekunle

“Characterization of Primary Biliary Cholangitis (PBC) in Canadian Patients” (Abstract #1916)
Eric Yoshida, Robert Bailey, Magdy Elkhashab, Dusanka Grbic, Nir Hilzenrat, Euiseok Kim, Gerald Minuk, Meaghan O'Brien, Kevork Peltekian, Marco Puglia, Alnoor Ramji, Mark Swain, Edward Tam, Cynthia Tsien, Catherine Vincent, Vlad Popovic, Jamie Twiselton, Belinda Yap

A full list of sessions at The Liver Meeting is available on the AASLD website at:

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