NEW YORK, March 29, 2011 /PRNewswire/ — Intercept
Pharmaceuticals, Inc., has been informed by the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) of the
National Institutes of Health that patient enrollment has started
in a new clinical trial in patients with nonalcoholic
steatohepatitis (NASH), which will evaluate Intercept’s
first-in-class farnesoid X receptor (FXR) agonist obeticholic acid
(OCA) as a novel therapy for NASH. The FXR Ligand NASH Treatment
(FLINT) trial is a double blind, placebo controlled, multi-center
clinical study that will evaluate the effects of OCA compared with
placebo in adult NASH patients.
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
mortality risk due to heart disease. NASH is now the most common
liver disease in the developed world, affecting at least 3-5% of
the U.S. population and up to 50% of patients with morbid obesity.
There is currently no approved treatment for the disease.
FLINT will enroll 280 patients at the eight U.S. centers
comprising the NIDDK-sponsored NASH Clinical Research Network.
The primary endpoint in the 72 week study will be determined
by liver biopsy and is defined as an improvement in the NAFLD
activity score with no worsening of liver fibrosis. NIDDK is
providing the majority of funding for the study and is partnering
with Intercept under a cooperative research and development
“It is a privilege to be collaborating with this group of
leading NASH investigators and the NIDDK,” commented David Shapiro,
MD, Chief Medical O