NEW YORK, July 28 /PRNewswire/ — Intercept
Pharmaceuticals, Inc., a clinical stage biopharmaceutical company
developing novel therapeutics for chronic fibrotic and metabolic
diseases, today announced the signing of a cooperative research and
development agreement (CRADA) with the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) of the National
Institutes of Health to conduct a double blind, multi-center, study
to evaluate the effects of obeticholic acid in patients with
nonalcoholic steatohepatitis (NASH). Obeticholic acid is the
generic name for INT-747, Intercept’s first-in-class FXR
agonist.
The planned study will enroll 280 patients at the eight U.S.
centers constituting the NIDDK-sponsored NASH clinical research
network (CRN), which will make it the largest study conducted in
this disease. The objectives of the 72 week study will be to
assess whether obeticholic acid improves histological disease
activity and other disease markers, along with the safety of the
drug in this patient population. The study is expected to begin in
the fourth quarter of 2010 and the NIDDK will provide a majority of
the funding needed under the CRADA.
NASH is a more serious form of nonalcoholic fatty liver disease
(NAFLD) and occurs in patients who drink little or no alcohol. The
disease is believed to be caused by abnormal metabolism of fats
and, although it is often associated with obesity and insulin
resistance, it also occurs in lean individuals. NASH is associated
with fibrosis (scarring) in the liver that may lead to cirrhosis,
liver cancer and death, and the disease also carries an additional
risk of death due to heart disease. NASH is now the most common
liver disease in the developed world, affecting at least 3 percent
of the U.S. population, and there is no approved treatment for the
disease.
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