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Intercept Announces Data to be Presented at the 2015 AASLD Annual Meeting
More Than 20 Abstracts Document Unmet Need in PBC and Provide Additional NASH Data From the FLINT Trial
November 03, 2015 07:05 ET | Source: Intercept Pharmaceuticals, Inc.
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: www.interceptpharma.com.
- See more at: http://globenewswire.com/news-re ... thash.xZdFI2YX.dpuf
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发表于 2015-11-4 12:56
