Intercept to Present New Data at EASL Congress 2024
Intercept Pharmaceuticals, Inc., a subsidiary of Alfasigma S.p.A., announced that nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease will be featured at the EASL Congress 2024 in Milan, Italy, from June 5-8. Intercept, which focuses on developing treatments for rare and severe liver diseases, will present new six-month data from its ongoing Phase 2 study evaluating the combination of obeticholic acid (OCA) and bezafibrate in PBC patients.
Sangeeta Sawhney, Senior Vice President and Head of U.S. Research & Development at Intercept, expressed enthusiasm about presenting the latest research on PBC. The six-month results from the ongoing Phase 2 studies demonstrate promising progress in treating PBC patients who do not respond adequately to or cannot tolerate ursodeoxycholic acid (UDCA). The company will also present analyses from the Phase 3 POISE trial, which further underscores their commitment to improving treatment options for PBC patients.
The EASL Congress 2024 presentations by Intercept include a variety of poster sessions. Key presentations include:
1. Late Breaker Poster Presentation:
"Combined effect of obeticholic acid and bezafibrate in patients with primary biliary cholangitis and inadequate response or intolerance to ursodeoxycholic acid: 6-month results from a Phase 2 trial" (Abstract #LB136).
2. PBC Poster Presentations:
"Time to initiation of the second-line therapy obeticholic acid in patients with primary biliary cholangitis" (Abstract #1278).
"Obeticholic acid normalizes inflammatory biomarkers in patients with primary biliary cholangitis" (Abstract #3230).
"Effect of obeticholic acid on reduction and normalization of alanine aminotransferase and aspartate aminotransferase in the Phase 3 POISE trial in primary biliary cholangitis" (Abstract #1322).
"Evaluation of aspartate aminotransferase to platelet ratio index and fibrosis-4 index stabilization in the Phase 3 POISE trial of obeticholic acid for the treatment of primary biliary cholangitis" (Abstract #1315).
"Stabilization of enhanced liver fibrosis and liver stiffness measures in the open-label extension of the Phase 3 POISE trial of obeticholic acid for the treatment of primary biliary cholangitis" (Abstract #1293).
"Association of elevated liver biochemistries and clinical outcomes within strata of alkaline phosphatase levels in patients with primary biliary cholangitis" (Abstract #1301).
3. Alcohol-related Liver Disease Poster Presentations:
"Farnesoid X receptor agonist INT-787 exhibits high intestinal localization" (Abstract #1313).
"Farnesoid X receptor agonist INT-787 protects human liver organoids from alcohol-induced injury" (Abstract #1320).
Additional information about these abstracts will be made available following the lifting of embargoes set by the EASL organizers.
Intercept is conducting two Phase 2 studies to explore the therapeutic potential of combining OCA and bezafibrate in treating PBC. The combination therapy targets both farnesoid X receptor (FXR) and peroxisome proliferator-activated receptor (PPAR) pathways, which are crucial in managing bile acid synthesis and metabolism. The investigational therapy aims to provide additional clinical efficacy and tolerability benefits for PBC patients.
Primary biliary cholangitis is a rare, chronic autoimmune disease affecting bile ducts in the liver, predominantly in women over 40. If untreated, it can lead to cirrhosis, liver transplant, or death. Ocaliva (OCA), marketed by Intercept, is an FXR agonist used to treat PBC in patients who do not respond to or cannot tolerate UDCA. However, Ocaliva treatment requires careful monitoring due to potential severe adverse reactions, including hepatic decompensation and failure.
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