Intercept Announces New Data in PBC and NASH to be Presented at EASL 2015
NEW YORK, April 13, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, announced today that several abstracts evaluating obeticholic acid (OCA) in patients with primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH) will be presented at the International Liver Congress 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL), being held in Vienna, Austria, from April 22-26, 2015. Intercept also announced abstracts relating to PBC to be presented by the Global PBC Study Group and the UK-PBC Group at EASL.
OCA is a first-in-class farnesoid X receptor (FXR) agonist in clinical development for a range of chronic liver diseases. Intercept has initiated a rolling New Drug Application with the FDA for PBC, and expects to complete the NDA and MAA submissions in 2Q 2015. OCA was also recently granted breakthrough therapy designation by FDA for the treatment of NASH patients with liver fibrosis.
"We are excited to be presenting new OCA clinical data in both PBC and NASH patients," said Mark Pruzanski, M.D., Chief Executive Officer of Intercept. "Furthermore, the Global PBC Study Group and UK-PBC Group analyses will provide the hepatology community with additional scientific insights into potential treatment goals for patients with PBC. This is timely as we prepare for the anticipated launch of OCA in the U.S. and Europe next year."
Intercept will be exhibiting at booth #340 throughout EASL. A schedule highlighting key presentations and events follows:
OCA Poster Presentations
25 April 13:00 - 13:30
"Integrated Efficacy Summary for Obeticholic Acid in Subjects with Primary Biliary Cirrhosis" (Poster P1137, Room A-01)
Pietro Invernizzi; Rich Pencek; Tonya Marmon; Leigh MacConell; David Shapiro
"FXR Agonism with Obeticholic Acid May Attenuate Bone Mineral Density Decrease in Subjects with Primary Biliary Cirrhosis" (Poster P1155, Room A-10)
Albert Pares; Rich Pencek; Yvette Peters; Tonya Marmon; Leigh MacConell; Luciano Adorini; David Shapiro; Michael Trauner; David Jones
25 April 15:30 - 16:00
"A Phase 3B, Double Blind, Placebo Controlled Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis at Elevated Risk of Progression to Liver Transplant or Death" (Poster P1321, Room C-01)
Keith Lindor; Bettina E. Hansen; Rich Pencek; Roya Hooshmand-Rad; Tonya Marmon; Leigh MacConell; David Shapiro; David Jones
OCA Late-Breaking Poster Presentation
25 April 15:30 - 16:00
"Obeticholic Acid for NASH: Benefits in a High Risk Subgroup and the Effects of Concomitant Statin Use" (Late-breaker Poster LP18, Room A-09)
Brent Neuschwander-Tetri; Arun Sanyal; Rohit Loomba; Naga Chalasani; Kris Kowdley; Manal Abdelmalek; Elizabeth Brunt; David Shapiro
Global PBC Study Group and UK-PBC Group Presentations
23 April 17:30 - 17:45
"The UK-PBC Risk Score: Derivation and Validation of a Risk Score to Predict Liver Events in the UK-PBC Research Cohort" (Oral Presentation Abstract O022, Strauss 1 room)
Marco Carbone; Stephen J. Sharp; Michael A. Heneghan; James M. Neuberger; Gideon M. Hirschfield; Andrew K. Burroughs; Douglas Thorburn; Andrew Bathgate; Mark Aldersley; Carolyn Adgey; Paul Trembling; Kate Williamson; Laura Jopson; Reyna T. Lim; Nick J. Wareham; Heather J. Cordell; Graeme J. Alexander; Jones E. Jones; Richard N. Sandford; George F. Mells; and UK-PBC Consortium
25 April 13:00 - 13:30
"Validation of Alkaline Phosphatase and Bilirubin Response Criteria as Biomarker for Transplant-Free Survival in Primary Biliary Cirrhosis in the World's Two Largest Cohorts" (Poster P1147, Room A-06)
Marco Carbone; Maren H. Harms; Keith Lindor; Gideon M. Hirschfield; Willem J. Lammers, Micheal Heneghan; Harry L.A. Janssen; James M. Neuberger; Douglas Thorburn; Albert Parès; Steven Sharp; Pietro Invernizzi; Nick Warheam; Annarosa Floreani; Andrew Bathgate; Christophe Corpechot; Mark Aldersley; Marlyn Mayo; Nick F. LaRusso; Frederik Nevens; Graeme J. Alexander; Kris W. Kowdley; Richard N. Sandford; Andrew L. Mason; David Jones; Henk R. van Buuren; George Mells; Bettina E. Hansen
A full list of sessions at EASL relating to OCA is available on the EASL website.
About Primary Biliary Cirrhosis
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. In Europe, the incidence of PBC is growing and the disease accounts for 50% of liver transplants for cholestatic disease and 6% of liver transplants overall.PBC is the second leading indication for liver transplant among women in the United States. Ursodiol is the only approved medication for PBC and studies have shown that up to 40% of PBC patients may have an inadequate response,thereby remaining at risk of adverse outcomes.
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases. The company's lead product candidate, obeticholic acid (OCA), is a first-in-class agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis (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 fibrosis and granted OCA fast track designation for the treatment of patients with PBC who have an inadequate response to or are intolerant of ursodiol. 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:
Intercept Pharmaceuticals | interceptpharma.com.
