Intercept Pharma (ICPT) Plans Presentation of Ocaliva Data in PBC at The Liver Meeting

November 1, 2016 7:13 AM EDT

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced multiple Ocaliva® (obeticholic acid) for PBC and INT-767 data presentations at the upcoming American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), taking place November 11 – 15 in Boston, MA.

“We have numerous presentations at this year’s Liver Meeting, among them an oral presentation examining Ocaliva’s effects on non-invasive fibrosis measurements in patients with PBC,” said David Shapiro, M.D., Intercept's Chief Medical Officer & Executive Vice President, Development. “Other PBC presentations include an evaluation of Ocaliva data using a long-term prognostic model developed by the UK-PBC Study Group and analyses of Ocaliva’s safety and efficacy in PBC patient populations with end-stage liver disease and renal disease. In addition, we look forward to sharing an analysis of fibrosis data from the FLINT trial in NASH and new preclinical research examining INT-767 – our FXR/TGR5 dual agonist – in animal models of NASH and metabolic disease.”

Intercept also announced its sponsorship of the new TARGET-NASH patient registry, which will advance the understanding of NASH diagnosis and management across multiple populations in a real world setting. As the NASH treatment landscape evolves, the registry will evaluate the safety and effectiveness of new agents across populations not included or underrepresented in Phase 3 clinical trials. TARGET-NASH is led by an academic steering committee chaired by Drs. Arun Sanyal of Virginia Commonwealth University, Ken Cusi of the University of Florida and Brent Tetri of St. Louis University. The registry is currently enrolling and additional details about TARGET-NASH are available at ClinicalTrials.gov.

In the United States, Ocaliva was recently approved by the FDA for the treatment primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Obeticholic acid is also being investigated for patients with NASH and liver fibrosis, as well as primary sclerosing cholangitis and biliary atresia.

Intercept will be exhibiting at booth 524 throughout the Liver Meeting. Select presentations include:

Oral Presentation:

Monday November 14, 3:00 pm - 4:30 pm ET“Long-Term Effect of Obeticholic Acid on Transient Elastography and AST to Platelet Ratio Index in Patients with PBC” (Abstract #209) Gideon M. Hirschfield, Annarosa Floreani, Palak J. Trivedi, Richard Pencek, Alexander Liberman, Tonya Marmon, Leigh MacConell

Posters Presentations in PBC and NASH:

“Efficacy of Obeticholic Acid Treatment in Patients with Primary Biliary Cholangitis with Cirrhosis” (Abstract #366)John M. Vierling, Gideon M. Hirschfield, David Jones, Roberto J. Groszmann, Kris V. Kowdley, Richard Pencek, Tonya Marmon, Leigh MacConell

“Predicted Risk of End Stage Liver Disease with Continued Standard of Care and Subsequent Addition of Obeticholic Acid in Patients with PBC” (Abstract #361) Kris V. Kowdley, Hemant Shah, Andrew Mason, Velimir A. Luketic, Richard Pencek, Tonya Marmon, David Shapiro, Roya Hooshmand-Rad

“Efficacy of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Renal Impairment” (Abstract #401) Paul J. Pockros, K. Gautham Reddy, Janet Owens-Grillo, Tonya Marmon, Leigh MacConell

“Subgroup Analysis Comparing Obeticholic Acid versus Placebo for Fibrosis Improvement: a Post-hoc Analysis of the FLINT Trial” (Abstract #1074) Bilal Hameed, Norah Terrault, Rohit Loomba, Arthur J. McCullough, Manal F. Abdelmalek, Kris V. Kowdley, Brent A. Tetri, Arun J. Sanyal, Lois Lee, Beatrice Ferguson, Reshma Shringarpure, David Shapiro, Naga P. Chalasani

INT-767 Preclinical Poster Presentations:

“The FXR/TGR5 Dual Agonist INT-767 Reduces NAFLD Activity Score and Fibrosis Stage and Improves Plasma and Hepatic Lipid Profiles in the GUBRA-AMLN Mouse Model of Diet-induced and Biopsy-confirmed Nonalcoholic Steatohepatitis” (Abstract #1508)Jonathan Roth, Michael Feigh, Sanne Skovgård Veidal, Kristoffer Rigbolt, Jacob Jelsing, Niels Vrang, Mark Young

“The dual FXR/TGR5 agonist INT-767 inhibits nonalcoholic steatohepatitis development in a rabbit model of metabolic syndrome” (Abstract #1521)Paolo Comeglio, Sandra Filippi, Ilaria Cellai, Elena Maneschi, Francesca Corcetto, Chiara Corno, Annamaria Morelli, Luciano Adorini, Mario Maggi, Linda Vignozzi

“The FXR/TGR5 dual agonist INT-767 prevents and reverses Western diet-induced NASH and modulates major lipid metabolic pathways in mice” (Abstract #1528)Xiaoxin Wang, Andrew Libby, Suman Ranjit, Dong Wang, Yuhuan Luo, David J. Orlicky, James McManaman, Evgenia Dobrinskikh, Enrico Gratton, Mark Young, Luciano Adorini, Moshe Levi

Obeticholic Acid Preclinical Poster Presentations:

“Obeticholic Acid Does Not Affect the Hepatic Metabolism of Hormonal Birth Control in Human Sandwich Cultured Hepatocytes” (Abstract #394)Jeffrey Edwards, Yuanyuan Zhang, Jonathan Jackson, Kenneth Brouwer

“Obeticholic acid reduces plasma HDL-cholesterol levels and promotes transhepatic cholesterol efflux in hyperlipidemic hamsters via a mechanism involving upregulation of hepatic SR-BI” (Abstract #1533) Bin Dong, Mark Young, Xueqing Liu, Amar Singh, Jingwen Liu

“Obeticholic acid, a synthetic FXR agonist, prevents hepatic inflammation and fibrosis in a novel mouse model of non-alcoholic steatohepatitis” (Abstract #1609) Toshihiro Goto, Michiko Itoh, Sayaka Kanai, Takayoshi Suganami,Yoshihiro Ogawa

A full list of sessions at AASLD, including symposia, relating to obeticholic acid is available on the AASLD website.



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