ICPT Intercept Pharmaceuticals Inc.

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference

MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024. The conference will be held from May 18-21 in Washington, D.C.

“We are pleased to participate in this year’s DDW and share our latest findings, including new data from our Phase 2 trial evaluating a fixed-dose combination of obeticholic acid and bezafibrate in patients with PBC,” said Sangeeta Sawhney, Senior Vice President and Head of U.S. Research & Development. “These data, along with new analyses from our landmark Phase 3 POISE trial, showcase our continued commitment to helping improve the lives of people living with PBC. We’re looking forward to sharing these data with the scientific community and learning about the latest in liver research.”

Presentations by Intercept at DDW 2024 include:

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” Session Number: 2395 (Abstract #155)

Saturday, May 18, 2:00 – 2:15 PM ET

Alan Bonder; David Jones; Cynthia Levy; Heng Zou; Antonio Civitarese; Fredrik Nevens

“Effect of Obeticholic Acid on APRI Score in Patients at Higher Risk for Fibrosis, as Determined by Higher Baseline Fibrosis-4 Score and Liver Stiffness: Sub-analysis of the Phase 3 POISE Trial in Primary Biliary Cholangitis” Session Number: 2395 (Abstract #156)

Saturday, May 18, 2:15 – 2:30 PM ET

Alan Bonder; Darren Wheeler; Jing Li; Christopher Gasink; Robert G. Gish

“Effect of Obeticholic Acid on Normalization of Alanine Aminotransferase and Aspartate Aminotransferase: Sub-analysis of the Phase 3 POISE Trial in Primary Biliary Cholangitis” Session Number: 4120 (Abstract #632)

Monday, May 20, 8:45 – 9:00 AM ET

Robert G. Gish; Darren Wheeler; Jing Li; Christopher Gasink; David W. Victor III

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” Session Number: 8240 (Abstract #1582)

Monday, May 20, 12:30 – 1:30 PM ET

Gideon Hirschfield; M. Alan Brookhart; Michael Fried; Leona Bessonova; Julia Chu; Darren Wheeler; Bettina Hansen; John Seeger; Sangeeta Sawhney; David Jones

“Hepatic Events in Patients with Primary Biliary Cholangitis Treated with Obeticholic Acid: 7 Years of Post-Marketing ExperienceSession Number: 8240 (Abstract #1598)

Monday, May 20, 12:30 – 1:30 PM ET

Cynthia Levy; David Jones; Islah Ahmed; Leona Bessonova; Darren Wheeler; Ludmila Kryzhanovskaya; Anne Chiplin; Keri-Ann Buchanan-Peart; Kris V. Kowdley

More information about these presentations will be made available after the respective embargoes, as set by the DDW organizers, are lifted for each presentation. A full list of sessions at DDW 2024 is available at .

Attendees of DDW can visit Intercept at booths #3741 and #3828 throughout the meeting.

About Digestive Disease Week®

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored 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 is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at

About Primary Biliary Cholangitis

Primary biliary cholangitis (PBC) is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death.

About Intercept

Intercept is a biopharmaceutical company and a wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). Intercept owns the commercial rights to Ocaliva in the U.S. market. For more information, please visit  or connect with the Company on ,  and .

Contact

For more information about Intercept, please contact:

For media:



EN
09/05/2024

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Intercept Pharmaceuticals Inc.

 PRESS RELEASE

Intercept Announces New PBC Data Analyses to be Presented at Digestive...

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024. The conference will be held from May 18-21 in Washington, D.C. “We are pleased to participate i...

 PRESS RELEASE

Intercept Announces FDA Acceptance of Supplemental New Drug Applicatio...

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBCPrecedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registriesFDA has assigned a PDUFA target action date of October 15, 2024 MORRISTOWN, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned...

 PRESS RELEASE

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA...

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023 Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint) Treatment-emergent adverse events were generally balan...

 PRESS RELEASE

Intercept Announces New Findings from Long-term Extension of Landmark ...

Intercept Announces New Findings from Long-term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD The Liver Meeting® 2023 New analysis demonstrates the impact of OCA on achievement of GGT

 PRESS RELEASE

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc. BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc. Following the completion of Alfasigma’s successful tender offer to purchase all outstanding shares of common stock of Intercept for USD 19.00 per share, net to the seller thereof in cash, without interest, less any applicable withh...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch