NEW YORK, March 31, 2011 /PRNewswire/ — Intercept
Pharmaceuticals, Inc., today announced positive results from a 59
patient, placebo controlled, double-blind Phase II clinical
trial of obeticholic acid (OCA) given as monotherapy to patients
with primary biliary cirrhosis (PBC). The study evaluated the
effects of 10 mg and 50 mg of OCA compared with placebo in patients
with elevated alkaline phosphatase (AP). AP is a liver enzyme
routinely used to evaluate the clinical status and disease
progression of PBC patients.
At the end of the 12 week treatment period, both doses of OCA
produced statistically highly significant reductions in AP, the
primary endpoint, compared with the patients receiving placebo
(changes: 10mg: -45%; 50mg: -38%; placebo: 0%; p
< 0.0001 both doses versus placebo). There were also significant
improvements in other liver enzymes, including gamma-glutamyl
transferase. In addition, serum markers of inflammation and
immunity also improved with significant reductions of C-reactive
protein (CRP), and immunoglobulin M (IgM), which is closely
associated with the autoimmune dysfunction in PBC. Pruritus
(itch) was seen more commonly in the OCA treated patients and
increased with dose; otherwise, all other adverse events were
generally similar across the groups.
PBC is a chronic autoimmune disease of the liver marked by the
slow progressive destruction of the small bile ducts within the
liver which may lead to liver failure and the need for
liver transplantation. PBC primarily afflicts women with
up to 300,000 patients estimated in developed countries.
There is only one drug approved to treat the disease,
ursodeoxycholic acid (UDCA), and up to 50% of PBC patients on UDCA
therapy continue to be at significant risk of progression to
cirrhosis.
Kris V. Kowdley, MD, Director of the Center for Liver Disease at
Virginia Mason Medical Center, in Seattle, Washington and a
princ
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