Ocera Therapeutics Presents Clinical Data Demonstrating AST-120 Relieves Pruritus in Patients with Liver Cirrhosis at the 60th Annual AASLD Meeting
AST-120 Also Shown to Reduce Ammonia and Brain Swelling in Rat Model of Cirrhosis
BOSTON, Nov. 2 /PRNewswire/ -- Ocera Therapeutics, Inc.
announced today that AST-120 (spherical carbon adsorbent) was shown
to reduce the severity of pruritus (itching) in patients with
chronic liver disease. The data were presented at the 60th Annual
Meeting of the American Association for the Study of Liver Diseases
in a presentation titled, "Oral AST-120 (Spherical Carbon
Adsorbent) Improves Pruritus and Lowers Serum Bile Acids in
Patients with Cirrhosis of Various Etiologies." These findings
comprised a secondary endpoint of a larger Phase 2 study
demonstrating the efficacy, safety and tolerability of AST-120 in
cirrhotic patients with mild hepatic encephalopathy (MHE).
Patients treated with AST-120 had a statistically significant
reduction in itch with a four-week treatment course. The benefit
was seen as early as the first week of therapy and continued to
improve over the four weeks of treatment. Mean reduction in
pruritus by 100mm VAS at Week 4 was 30mm for AST-120 treated
subjects vs. 5mm for placebo treated subjects, p=0.03. The
reduction in itch was significantly correlated with a reduction in
serum bile acids, which are thought to play a key role in the
pathogenesis of pruritus in this patient population.
"Pruritus affects up to 15 percent of hepatitis C patients, and
can be devastating for chronic liver disease patients," said
Averell Sherker, M.D. Director of the Center for Liver Diseases at
the Washington Hospital Center and the presenting investigator.
"The efficacy seen with AST-120 in this limited sample of patients,
coupled with its well established safety profile, suggests that it
has the potential to become an important treatment option for these
patients in the future."
In a separate session at AASLD, Christopher Rose, Ph.D.,
Assistant Professor in the Department of Medicine at Universite de
Montreal, presented the results of a preclinical study conducted
with AST-120 in a rat model of cirrhosis. In that study, titled
"AST-120 (spherical carbon adsorbent) attenuates brain edema and
lowers arterial ammonia in bile-duct ligated rats," the
administration of AST-120 resulted in a statistically significant
reduction in serum ammonia levels and brain swelling. Increased
serum ammonia is recognized as a central feature of hepatic
encephalopathy and related complications.
The efficacy and safety of AST-120 in the treatment of MHE, the
most frequent complication of cirrhosis, is currently being
evaluated by Ocera in the ongoing ASTUTE Phase 2b study. MHE
affects up to 60 percent of cirrhotic patients and is associated
with neurocognitive deficits leading to an increased risk of car
accidents, falls, loss of employment and reduced quality of
"AST-120 avidly binds ammonia, bile acids and many other
potentially toxic substances from the lower gastrointestinal tract.
In addition to showing great potential for the treatment of MHE and
for the relief of pruritus, these data demonstrate AST-120 warrants
further clinical evaluation for the treatment of other liver and
gastrointestinal diseases," said Scott Harris, M.D. Ocera's Chief
AST-120 is a novel proprietary microspherical carbon adsorbent
with a selective adsorption profile for a variety of unwanted
substances in the digestive tract. These substances may be
responsible for a number of conditions, including hepatic
encephalopathy (HE), irritable bowel syndrome (IBS), and pouchitis.
The substances include ammonia, indoles (serotonin, octopamine),
histamine, secondary bile acids, advanced glycation endproducts
(AGE), and certain bacterial toxins. Ocera licensed the compound
from the Kureha Corporation (Japan) in 2005.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, based in San Diego, California, USA, is a
privately held biopharmaceutical company focused on the development
and commercialization of proprietary compounds to treat acute and
chronic liver diseases and a broad range of gastrointestinal
disorders. In addition to AST-120, Ocera is developing OCR-002 in
hepatic encephalopathy due to complications of cirrhosis and acute
liver failure. Ocera has raised $62 million in venture financing
from Domain Associates, Sofinnova Ventures, Thomas, McNerney &
Partners, Montagu Newhall and InterWest Partners.
Posted: November 2009