Cboe Global Markets : Intercept To Present Results From Phase 3 Trial Patients with Liver Fibrosis Due to NASH at the International Liver Congress™ 2019

Intercept To Present Results From Phase 3 Trial Patients with Liver Fibrosis Due to NASH at the International Liver Congress™ 2019

Benzinga Newsdesk 4/4/2019 6:04:10 AM

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 OCA abstracts will be presented at the International Liver Congress™ 2019, the 54th Annual Meeting of the European Association for the Study of the Liver (EASL), in Vienna, Austria from April 10, 2019 through April 14, 2019.

'We are thrilled to be presenting our groundbreaking Phase 3 REGENERATE results during the Opening Ceremony and General Session of the 2019 International Liver Congress, which promises to be a watershed event for the hepatology community,' said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. 'In addition to REGENERATE, we will be presenting a late-breaking poster on a placebo-controlled study of OCA showing physiologic improvement of liver function in NASH patients with fibrosis, as assessed by the HepQuant quantitative liver function test. In PBC, we are looking forward to a late-breaking oral presentation of an investigator-initiated study which showed that the addition of bezafibrate to OCA improved both cholestasis and pruritus, underscoring the rationale for our plan to develop a fixed dose combination of these two agents.'
Presentations at the International Liver Congress include:
Oral Presentations
General Session and Opening Ceremony Oral Presentation
Thursday, April 11, 2019 from 3:15 - 3:30 p.m. CEST
'Positive Results from REGENERATE: A Phase 3 International, Randomized, Placebo-Controlled Study Evaluating Obeticholic Acid Treatment for NASH' (Abstract GS-06)
Zobair Younossi, Vlad Ratziu, Rohit Loomba, Mary Rinella, Quentin M. Anstee, Zachary Goodman, Pierre Bedossa, Andreas Geier, Susanne Beckebaum, Philip Newsome, David Sheridan, James Trotter, Whitfield Knapple, Eric Lawitz, Kris Kowdley, Aldo Montano-Loza, Jerome Boursier, Philippe Mathurin, Elisabetta Bugianesi, Guiseppe Mazzella, Antonio Olveira, Helena Cortez-Pinto, Isabel Graupera, David Orr, Lise Lotte Gluud, Jean-Francois Dufour, David Shapiro, Jason Campagna, Luna Zaru, Leigh MacConell, Reshma Shringarpure, Stephen Harrison, Arun Sanyal
Late-Breaker Oral Presentation
Saturday, April 13, 2019 from 5:00 - 5:15 p.m. CEST
'Bezafibrate improves the effect of obeticholic acid on cholestasis in patients with primary biliary cholangitis' (Abstract LB-05)
Lena Smets, Liliane Schrijvers, Hannelie Korf, Schalk Van der Merwe, Frederik Nevens
Poster Presentations
Late-Breaker Poster Presentation
Thursday, April 11, 2019 from 9:00 a.m. - 5:00 p.m. CEST
'Effect of Obeticholic Acid on Liver Function in Patients with Fibrosis due to NASH' (Abstract LBP-18)
Naim Alkhouri, Gregory Everson, Steve Helmke, Jianfen Chen, Carl LaCerte, Michael Stenkilsson, Jeffrey Edwards
General Poster Presentations
Friday, April 12, 2019 from 9:00 a.m. - 5:00 p.m. CEST
'Inadequate response to UDCA among PBC patients under routine care in the US: Rising serum bilirubin even in the normal range is a risk factor and subsequent clinical follow-up differs based on treatment response' (Abstract FRI-023)
Stuart C. Gordon, Talan Zhang, Christopher L. Bowlus, Keith Lindor, Carla V. Rodriguez, Robert J. Romanelli, Irina V. Haller, Heather Anderson, Jeffrey J. VanWormer, Joseph A. Boscarino, Mark A. Schmidt, Yihe G. Daida, Amandeep Sahota, Jennifer Vincent, Kuan-Han Hank Wu, Sheri Trudeau, Jia Li, Christina Melkonian, Loralee B. Rupp, Mei Lu
'Long-term assessment of the effects of obeticholic acid in patients with primary biliary cholangitis on immune and inflammatory markers'(Abstract FRI-026)
Gideon M. Hirschfield, Frederik Nevens, Mitchell L. Shiffman, Joost P.H. Drenth, Christopher L. Bowlus, Victor Vargas, Pietro Andreone, Alexander Liberman, Elizabeth Smoot Malecha, Leigh MacConell, Michael Traunder
'Long-term obeticholic acid treatment is associated with improvements in collagen morphometry in patients with primary biliary cholangitis' (Abstract FRI-033)
Andreas E. Kremer, Christopher L. Bowlus, Pierre Bedossa, Albert Parés, Lisa M. Forman, Joost P.H. Drenth, Stephen Ryder, Luigi Terracciano, Yuying Jin, Alexander Liberman, Richard Pencek, Leigh MacConell, Paul J. Pockros
'Change in lipids: Characteristics and response to obeticholic acid in TARGET-PBC, a diverse, large United States real-world cohort'(Abstract FRI-037)
Cynthia Levy, Marlyn J. Mayo, Elizabeth J. Carey, Ester C. Little, W. Ray Kim, Karen Deane, Richard Zink, Robert Sandefur, Christopher L. Bowlus
'Primary biliary cholangitis - Autoimmune hepatitis overlap syndrome: Characteristics and response to obeticholic acid in TARGET-PBC, a diverse, large United States real-world cohort'(Abstract FRI-043)
Marlyn J. Mayo, Christopher L. Bowlus, Elizabeth J. Carey, Ester C. Little, Karen Deane, Richard Zink, Robert Sandefur, W. Ray Kim, Cynthia Levy
Saturday, April 13, 2019 from 9:00 a.m. - 5:00 p.m. CEST
'Evaluation of anti-fibrotic properties of OCA and INT-767 in an in vitro system of NAFLD' (Abstract SAT-337)
Beatrice Anfuso, Natalia Rosso, Luciano Adorini, Claudio Tiribelli
'Morphometric collagen analysis discerns anti-fibrotic effects of INT-767 and OCA in NASH mouse models using second harmonic generation imaging' (Abstract SAT-342)
Li Chen, Mathieu Petitjean, Luciano Adorini, Jonathan Roth
'Obeticholic acid reduces matrix metalloproteinases activity via iNOS modulation in hepatic ischemia/reperfusion injury' (Abstract SAT-389)
Laura G. Di Pasqua, Guiseppina Palladini, Clarissa Berardo, Veronica Siciliano, Luciano Adorini, Plinio Richelmi, Massimiliano Cadamuro, Luca Fabris, Stefano Perlini, Mariapia Vairetti, Andrea Ferrigno