Intercept Announces Data to be Presented at the 2015 AASLD Annual Meeting

NEW YORK, Nov. 3, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic, underserved liver diseases, today announced data presentations at the upcoming American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), taking place November 13 – 17 in San Francisco, CA.

Intercept is presenting more than 20 abstracts on obeticholic acid (OCA), the company's lead farnesoid X receptor (FXR) agonist, primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), and nonalcoholic steatohepatitis (NASH) at The Liver Meeting. These abstracts examine the scope and unmet need in PBC, differences in physician and patient perceptions of PBC, and the clinical profile of OCA in the treatment of PBC and NASH, including non-invasive predictors of fibrosis improvement and OCA treatment response from the FLINT trial. New preclinical data will also be presented at the meeting, including an oral presentation highlighting the efficacy of Intercept's dual FXR/TGR5 agonist INT-767 in NASH.

"Our understanding of PBC and the unmet need in the treatment of this disease has grown steadily in recent years and we believe that, once approved, OCA will be of real value as an additional therapeutic option for many PBC patients," said David Shapiro, M.D., Intercept's Chief Medical Officer & Executive Vice President, Development. "At the same time, we are making good progress in our NASH program with the ongoing enrollment of our Phase 3 REGENERATE trial evaluating OCA in non-cirrhotic NASH patients with advanced liver fibrosis. We look forward to working with the medical community to further advance the understanding of OCA's utility in this underserved patient population with no approved medical treatment options."

Intercept will be exhibiting at Booth 313 throughout the meeting. Select presentations at The Liver Meeting include:

Oral Presentations – Clinical:

Sunday, November 15, 5:15 p.m. in Moscone Center, Room 2020
"Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large US Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase" (Abstract #75)
W. Ray Kim, Tracy J. Mayne, Tonya Marmon, David Shapiro, Keith D. Lindor

Monday, November 16, 5:45 p.m. in Moscone Center, Room 2024
"A Trial-based Model of Liver Transplant and Liver-related Death in Patients with Primary Biliary Cirrhosis" (Abstract #155)
Marco Carbone, Richard Pencek, Tracy J. Mayne, Tonya Marmon, George F. Mells, David Shapiro

Tuesday, November 17, at 12:15 p.m. in Moscone Center, Room 2016
"Longitudinal changes in FIB-4 and improvement in fibrosis stage with obeticholic acid: A secondary analysis of FLINT Trial" (Abstract #239)
Naga P. Chalasani, Rohit Loomba, Norah Terrault, Arthur J. McCullough, Manal F. Abdelmalek, Kris V. Kowdley, Brent A. Neuschwander-Tetri, Saswati Hazra, Xiaohong Yan, Reshma Shringarpure, Leigh MacConell, Arun J. Sanyal

Oral Presentations – Preclinical:

Monday, November 16, at 3:45 p.m. in Moscone Center, Room 3020
"Treatment with the FXR-TGR5 dual agonist INT-767 arrests and reverses progression of NASH in mice fed a Western diet" (Abstract #142)
Xiaoxin Wang, Yuhuan Luo, David J. Orlicky, Luciano Adorini, Moshe Levi

Monday, November 16, at 5:00 p.m. in Moscone Center, Room 2020
Enteral Obeticholic Acid Prevents Hepatic Cholestasis in Total Parenteral Nutrition-Fed Neonatal Pigs (Abstract #194)
Douglas Burrin, Yanjun Jiang, Zhengfeng Fang, Barbara Stoll, Gregory J. Guthrie, Hongtao Wang, Ignacio R. Ipharraguerre, Jose J. Pastor

Posters on OCA and the Investigational Treatment of PBC:

"Sustained Improvement in the Markers of Cholestasis in an Open Label Long Term Safety Extension Study of Obeticholic Acid in Primary Biliary Cirrhosis Patients" (Abstract #609)
Michael Trauner, Frederik Nevens, Pietro Andreone, Giuseppe Mazzella, Simone I. Strasser, Christopher L. Bowlus, Pietro Invernizzi, Joost Drenth, Paul J. Pockros, Jaroslaw Regula, Annarosa Floreani, Simon Hohenester, Velimir A. Luketic, Mitchell L. Shiffman, Karel J. van Erpecum, Victor Vargas, Catherine Vincent, Bettina E. Hansen, Roya Hooshmand-Rad, Shawn Sheeron, David Shapiro

"Efficacy and Safety of Obeticholic Acid (OCA) in PBC Patients with Advanced Disease as Evidenced by Abnormal Bilirubin: An Integrated Analysis" (Abstract #625)
David Jones, Richard Pence, Roya Hooshmand-Rad, David Shapiro

"Long-term safety and efficacy of Obeticholic Acid Treatment in Primary Biliary Cirrhosis after more than 4 years of treatment" (Abstract #628)
Kris V. Kowdley, Hemant Shah, Andrew Mason, Velimir A. Luketic, Richard Pencek, Tonya Marmon, David Shapiro, Roya Hooshmand-Rad

"Long-Term Safety of OCA in Patients with PBC" (Abstract #644)
Yvette Peters, Roya Hooshmand-Rad, Richard Pencek, Janet Owens-Grillo, Tonya Marmon, Leigh MacConell, David Shapiro

Posters on PBC Health Economics Outcomes Research:

"Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis" (Abstract #537)
Andrew Saich, Herbert Swanson, Tracy J. Mayne

"Characteristics of Incident PBC Patients in a Large US Laboratory Sample" (Abstract #562)
Keith D. Lindor, Tracy J. Mayne, Herbert Swanson, David Shapiro, W. Ray Kim

"Convergence of Two Predictive Models of Risk Reduction in Patients with Primary Biliary Cirrhosis" (Abstract #601)
Bettina E. Hansen, Willem J. Lammers, David Jones, Henk R. van Buuren, George F. Mells, Marco Carbone

Posters on OCA and the Investigational Treatment of NASH:

"Predictors of improvement in NAFLD Activity Score to obeticholic acid: A secondary analysis of FLINT Trial" (Abstract #2154)
Rohit Loomba, Arun J. Sanyal, Kris V. Kowdle, Norah Terrault, Naga P. Chalasani, Manal F. Abdelmalek, Arthur J. McCullough, Xiaohong Yan, Reshma Shringarpure, Beatrice Ferguson, David Shapiro, Brent A. Neuschwander-Tetri

"Effect of biopsy length on histological response assessment in NASH trials: A secondary analysis of FLINT Trial" (Abstract #2153)
Manal F. Abdelmalek, Kris V. Kowdley, Norah Terrault, Brent A. Neuschwander-Tetri, Arun J. Sanyal, Rohit Loomba, Xiaohong Yan, Reshma Shringarpure, David Shapiro, Arthur J. McCullough

Other Presentations

Intercept will webcast an investor event on Monday, November 16, 2015 starting at 8:30 p.m. PT. During this webcast, management and thought leaders will review Intercept's development programs, including PBC and NASH.

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

About Primary Biliary Cirrhosis, also known as Primary Biliary Cholangitis

PBC is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. Since 1988, PBC has been the second-leading overall cause of liver transplant in women in the United States, behind hepatitis C. In Europe, the disease accounts for approximately half of liver transplants due to cholestatic diseases and 6% of all liver transplants.

About Nonalcoholic Steatohepatitis

NASH is a serious chronic liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. There are currently no drug therapies approved for the treatment of NASH. Patients with early disease but with risk factors such as diabetes, obesity or elevated ALT are at increased risk of progression to cirrhosis. The proportion of liver transplants attributable to NASH has increased rapidly in past years and by 2020 the disease is projected to become the leading indication for liver transplant ahead of chronic hepatitis C and alcoholic liver disease.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases. The Company's lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with liver fibrosis and granted OCA fast track designation for the treatment of patients with PBC. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. For more information about Intercept, please visit the Company's website at:

Safe Harbor Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical, preclinical and regulatory developments for Intercept's product candidates, the anticipated results of Intercept's clinical trials and preclinical studies and other development activities and the timing thereof, Intercept's potential development and regulatory milestones and the timeframes under which it anticipates such milestones may be achieved, Intercept's plans to continue its development program for OCA in NASH as currently designed, the ability of past results to predict future results, the clinical utility of our selected endpoint and any potential consensus relating thereto, and Intercept's strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates it may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; Intercept's plans to research, develop and commercialize its product candidates; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's ability to obtain and maintain intellectual property protection for its product candidates; Intercept's ability to successfully commercialize its product candidates; the size and growth of the markets for Intercept's product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; Intercept's ability to retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in Intercept's annual report on Form 10-K for the year ended December 31, 2014 filed on March 2, 2015 as well as any updates to these risk factors filed from time to time in other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.

CONTACT: For more information about Intercept Pharmaceuticals, please contact: Mark Vignola +1-646-747-1000 Media inquiries: Investor inquiries:

Source:Intercept Pharmaceuticals, Inc.