Intercept Announces New Data to be Presented in PBC, Liver Fibrosis due to NASH and Pipeline at ...

Data from Phase 3 REGENERATE study supporting positive benefit-risk profile of obeticholic acid (OCA) in liver fibrosis due to NASH to be featured in late-breaker podium presentation

Analysis demonstrating improvement in outcomes, including transplant-free survival, for PBC patients treated with OCA vs. placebo and external controls to be presented

New data on INT-787, Intercept’s next generation FXR agonist, to be featured in two posters

MORRISTOWN, N.J., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced multiple abstracts on obeticholic acid (OCA) and INT-787, a next-generation FXR agonist, will be presented at The Liver Meeting® 2022, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting® will be held from November 4 – 8, 2022, in Washington, D.C.

“We are pleased to participate in The Liver Meeting® in-person this year, where we will be sharing a breadth of data that demonstrate the clinical benefits of OCA in both PBC and liver fibrosis due to NASH, as well as select preclinical and early clinical data for our next generation FXR agonist, INT-787,” said M. Michelle Berrey, M.D., MPH, President of R&D and Chief Medical Officer of Intercept. “We are especially excited to share additional analyses of our pivotal REGENERATE study, which we believe further support the positive benefit:risk profile of OCA in liver fibrosis due to NASH. The comprehensive safety analyses and new consensus histology reads from REGENERATE will be included in the new drug application we plan to re-submit by the end of this year.”

The use of OCA for fibrosis due to NASH is investigational and has not been approved by the U.S. Food and Drug Administration or any other health authority.

Presentations at The Liver Meeting include:

Late-breaking Oral Presentation in Fibrosis due to NASH
“Topline Results from a New Analysis of the REGENERATE Trial of Obeticholic Acid for the Treatment of Nonalcoholic Steatohepatitis” (Abstract #5008)
Arun J. Sanyal, Rohit Loomba, Quentin M. Anstee, Vlad Ratziu, Kris V. Kowdley, Mary E. Rinella, Muhammad Y. Sheikh, James F. Trotter, Whitfield L. Knapple, Eric J. Lawitz, Manal F. Abdalmalek, Philip N. Newsome, Jerome Boursier, Philippe Mathurin, Jean-Francois Dufour, M. Michelle Berrey, Steven J. Shiff, Sangeeta Sawhney, Thomas Capozza, Rina Leyva, Stephen A. Harrison and Zobair M. Younossi

Late-breaking PBC Poster
“Efficacy of Obeticholic Acid (OCA) vs. Placebo and External Control (EC) on Clinical Outcomes in Primary Biliary Cholangitis (PBC)" (Abstract #5032)
Kris V. Kowdley, M. Alan Brookhart, Gideon M. Hirschfield, Charles Coombs, Elizabeth Malecha, Tracy Mayne, Erik Ness, Jing Li, Alexander Breskin, Nuvan Rathnayaka, George Mells, David Jones, Palak J. Trivedi, Bettina E. Hansen, Rachel Smith, James Wason, Shaun Hiu, Dorcas N. Kareithi, Andrew L. Mason, Christopher L. Bowlus, Kate Muller, Marco Carbone, Marina Berenguer, Piotr Milkiewicz, Femi Adekunle and Alejandra Villamil

PBC Oral Presentation
“Results of the HEROES study: Treatment Efficacy of Obeticholic Acid on Hepatic Real-World Outcomes in Patients with Primary Biliary Cholangitis” (Abstract #223)
M. Alan Brookhart, Charles Coombs, Alexander Breskin, Tracy J. Mayne, Erik Ness, Michael W. Fried, Bettina E. Hansen, C. Fiorella Murillo Perez and Gideon M. Hirschfield

INT-787 Poster Presentations
“Safety, Tolerability and Pharmacokinetics of Oral INT-787, A Novel Modified Bile Acid FXR Agonist, In Healthy Volunteers” (Abstract #4758)
Thomas Capozza, Jennifer Burkey, Jeroen Van De Wetering, Reinhold Kerb, Ms. Jennifer Callahan, Ludmila Kryzhanovskaya, Kelly Hughes and Mary Erickson

“The Novel FXR Agonist INT-787 Shows Higher Efficacy as Well as Greater Hepatic And Ileal Gene Modulation Than Obeticholic Acid in The Gubra-AMLN Mouse Model of Diet-Induced and Biopsy-Confirmed Nonalcoholic Steatohepatitis” (Abstract #2514)
Luciano Adorini, Dr. Kristoffer Rigbolt, Kristoffer Voldem-Clausen, Dr. Michael Feigh, Amuthakannan Subramaniam and Mary Erickson

A full list of sessions at The Liver Meeting® 2022 is available at  www.aasld.org/the-liver-meeting.

Attendees at The Liver Meeting® can visit Intercept at booths #735, #845 and #549 throughout the meeting.

About the REGENERATE Study
REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled, multicenter, international study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH. A pre-specified interim analysis was conducted in 931 subjects who had a liver biopsy at Month 18 to assess the effect of OCA on liver histology as compared to baseline biopsies. REGENERATE is fully enrolled with 2,480 randomized participants and is expected to continue while collecting data on the incidence of clinical outcomes for verification and description of clinical benefit. The end-of-study primary endpoint will compare the impact of treatment group (placebo, OCA 10 mg or OCA 25 mg daily) on all-cause mortality and liver-related clinical outcomes, as well as on long-term safety.

About Liver Fibrosis due to NASH
Nonalcoholic steatohepatitis (NASH) is a serious progressive 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. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. There are currently no medications approved for the treatment of NASH.

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 focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). For more information, please visit  www.interceptpharma.com  or connect with the Company on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements (FLS), including regarding resubmission and timing of Intercept’s new drug application for OCA for treatment of liver fibrosis due to NASH. Important factors could cause actual results to differ materially from the FLS. For example, our resubmission could be delayed or be unsuccessful because of efficacy, safety, or tolerability concerns, problems with our clinical studies and their data or methods, or our inability to address to the satisfaction of the FDA the issues raised in their complete response letter of June 2020 responding to our earlier submission.

Contact

For more information about Intercept, please contact:

For investors:
Nareg Sagherian, Executive Director, Global Investor Relations
Investors@interceptpharma.com

For media:
Karen Preble, Executive Director, Global Corporate Communications
Media@interceptpharma.com