Intercept to Present New PBC Data Analyses at Digestive Disease Week 2024

MORRISTOWN, N.J., May 09, 2024 - Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A., is dedicated to developing and commercializing innovative treatments for rare and serious liver diseases. The company announced that five of their abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024. This conference is scheduled to take place from May 18-21 in Washington, D.C.

Sangeeta Sawhney, Senior Vice President and Head of U.S. Research & Development at Intercept, expressed enthusiasm about participating in this year’s DDW, where they will present new data from their Phase 2 trial on a fixed-dose combination of obeticholic acid and bezafibrate for PBC patients. She emphasized that these findings, alongside new analyses from the Phase 3 POISE trial, demonstrate the company’s ongoing commitment to improving the lives of those with PBC. Sawhney looks forward to sharing these insights with the scientific community and learning about the latest advancements in liver research.

Intercept’s presentations at DDW 2024 include:

1. Oral Presentations:
- Metabolic Outcomes and Key Efficacy Data from a Phase 2 Trial Evaluating Combination Obeticholic Acid and Bezafibrate in Patients with Primary Biliary Cholangitis will be presented by Alan Bonder, David Jones, Cynthia Levy, Heng Zou, Antonio Civitarese, and Fredrik Nevens. This session (Abstract #155) is scheduled for Saturday, May 18, from 2:00 – 2:15 PM ET.
- Effect of Obeticholic Acid on APRI Score in Patients at Higher Risk for Fibrosis, Determined by Higher Baseline Fibrosis-4 Score and Liver Stiffness: Sub-analysis of the Phase 3 POISE Trial in Primary Biliary Cholangitis will be presented by Alan Bonder, Darren Wheeler, Jing Li, Christopher Gasink, and Robert G. Gish. This session (Abstract #156) will follow on Saturday, May 18, from 2:15 – 2:30 PM ET.
- Effect of Obeticholic Acid on Normalization of Alanine Aminotransferase and Aspartate Aminotransferase: Sub-analysis of the Phase 3 POISE Trial in Primary Biliary Cholangitis will be presented by Robert G. Gish, Darren Wheeler, Jing Li, Christopher Gasink, and David W. Victor III. This session (Abstract #632) is set for Monday, May 20, from 8:45 – 9:00 AM ET.

2. Poster Presentations:
- Safety Analysis of the Current US Prescribing Information–Indicated Population from the HEROES Study of Obeticholic Acid in Patients with Primary Biliary Cholangitis will be presented by Gideon Hirschfield, M. Alan Brookhart, Michael Fried, Leona Bessonova, Julia Chu, Darren Wheeler, Bettina Hansen, John Seeger, Sangeeta Sawhney, and David Jones. This session (Abstract #1582) is scheduled for Monday, May 20, from 12:30 – 1:30 PM ET.
- Hepatic Events in Patients with Primary Biliary Cholangitis Treated with Obeticholic Acid: 7 Years of Post-Marketing Experience will be presented by Cynthia Levy, David Jones, Islah Ahmed, Leona Bessonova, Darren Wheeler, Ludmila Kryzhanovskaya, Anne Chiplin, Keri-Ann Buchanan-Peart, and Kris V. Kowdley. This session (Abstract #1598) will also take place on Monday, May 20, from 12:30 – 1:30 PM ET.

Digestive Disease Week® (DDW) is recognized as the largest international gathering for professionals in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Sponsored jointly by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW 2024 will be held both in-person and online from May 18-21. The meeting is set to feature over 4,400 abstracts and numerous lectures on the latest developments in gastrointestinal research, medicine, and technology.

Primary biliary cholangitis (PBC) is an uncommon, progressive autoimmune disease that primarily affects the bile ducts in the liver. It is most frequently observed in women over 40 years old. The disease causes bile acid accumulation in the liver, leading to inflammation and fibrosis, which can progress to cirrhosis, necessitate a liver transplant, or result in death if untreated.

Intercept Pharmaceuticals focuses on creating and marketing new treatments for rare and serious liver conditions, such as PBC and severe alcohol-associated hepatitis (sAH). The company holds the commercial rights to Ocaliva in the United States.

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