Intercept Announces Multiple New Ocaliva® (obeticholic acid) Data Presentations at the International Liver Congress™ 2018
“We’re very excited to share the first biopsy-based clinical data supporting OCA's ability to reverse or stabilize fibrosis and cirrhosis in patients with PBC,” said
Late-Breaking Poster Presentation
“Long-Term Obeticholic Acid Treatment Associated with Reversal or Stabilization of Fibrosis/Cirrhosis in Patients with Primary Biliary Cholangitis”
“Steroidal and Non-Steroidal FXR Agonists Elicit Clinically Relevant Lipoprotein Profiles in Mice with Chimeric Humanized Livers”
Clinical Poster Presentations
“Treatment with Obeticholic Acid in Patients with NASH Does Not Show Increased Markers of Liver Toxicity Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH)”
“Primary Biliary Cholangitis in the U.S.: Real World Effectiveness of Obeticholic Acid in
“Durable Response in the Markers of Cholestasis through 36 Months of Open-Label Extension Study of Obeticholic Acid in Primary Biliary Cholangitis”
“Change in Bilirubin with Obeticholic Acid Treatment in Primary Biliary Cholangitis Patients with High Baseline Bilirubin: A Retrospective Analysis of POISE, 201, and 202”
“Disease Severity, Obeticholic Acid Disposition and Dose Selection in Patients with Biliary
Preclinical Poster Presentations
“Combined Administration of Obeticholic Acid and GFT-505: Additive Histological Improvements in Mice with Diet-induced and Biopsy-confirmed Non-alcoholic Steatohepatitis”
“Fibrosis Involves Increased Fibroblast and Hepatocyte Collagen Species, Reflecting the Interstitial and Basement Membrane Matrix: Restoration of the Local Tissue Milieu with FXR Agonism”
A full list of sessions at the
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population.
About Ocaliva® (obeticholic acid)
Ocaliva is indicated in
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP), as a surrogate endpoint which is reasonably likely to predict clinical benefit, including an improvement in liver transplant free-survival. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Intercept is currently enrolling COBALT, a Phase 4 clinical outcomes trial of Ocaliva in patients with PBC with the goal of confirming clinical benefit on a postmarketing basis.
EU IMPORTANT SAFETY INFORMATION
Hypersensitivity to the active substance or to any of the excipients and complete biliary obstruction.
Warnings and Precautions
Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been observed in patients taking obeticholic acid. Clinical signs and symptoms of hepatic decompensation have also been observed. These events have occurred as early as within the first month of treatment. Liver-related adverse events have primarily been observed at doses higher than the maximum recommended dose of 10 mg once daily. Patients should be monitored during treatment with Ocaliva for elevations in liver biochemical tests and for the development of liver-related adverse events. Dosage adjustments are needed for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Severe pruritus was reported in 23% of patients treated with Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm and 7% of patients in the placebo arms. The median time to onset of severe pruritus was 11, 158 and 75 days for patients in the Ocaliva 10 mg, Ocaliva titration and placebo arms, respectively. Management strategies include the addition of bile acid binding resins or antihistamines, dose reduction, reduced dosing frequency and/or temporary dose interruption.
The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%). Other common adverse reactions observed in clinical trials (> 5%) were abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality and eczema.
Bile acid binding resins such as cholestyramine, colestipol or colesevelam adsorb and reduce bile acid absorption and may reduce efficacy of obeticholic acid. When concomitant bile acid binding resins are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible.
For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics.
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), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. Founded in 2002 in New York, Intercept now has operations in the United States, Europe and Canada. For more information about Intercept, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.
This press release contains forward-looking statements, including, but not limited to, statements regarding the progress, timing and results of Intercept’s clinical trials, including its clinical trials for the treatment of nonalcoholic steatohepatitis (“NASH”), the safety and efficacy of Intercept’s approved product, Ocaliva (obeticholic acid or “OCA”), the potential approval of OCA in indications other than primary biliary cholangitis (“PBC”) and the timing and potential commercial success of OCA and any other product candidates Intercept may develop.
These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Intercept undertakes no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by Intercept’s management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. The following represent some, but not necessarily all, of the factors that could cause actual results to differ materially from historical results or those anticipated or predicted by Intercept’s forward-looking statements: Intercept’s ability to successfully commercialize Ocaliva in PBC; Intercept’s ability to maintain its regulatory approval of Ocaliva in PBC in
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Source: Intercept Pharmaceuticals, Inc.