Ocera Therapeutics, Inc., a
privately-held biopharmaceutical company focused on the development and
commercialization of proprietary compounds to treat gastrointestinal and
liver diseases announced that data from the first cohort of patients
from an exploratory Phase 2 study evaluating the efficacy and safety of
AST-120 in patients with active pouchitis was presented in a poster
presentation at the American College of Gastroenterology Annual Scientific
Meeting.
"A four-week treatment with AST-120 in patients with active pouchitis
led to a significant decrease in symptoms of pouchitis and endoscopy scores
in the first ten patients enrolled in the study," said Dr. Bo Shen,
principal investigator at the Center for Inflammatory Bowel Disease,
Cleveland Clinic. "These results were impressive with 44.4% of the patients
achieving clinical remission and 55.6% achieving a clinical response."
"These promising results warrant the further evaluation of AST-120 for
the treatment of pouchitis in controlled randomized studies," added Laurent
Fischer, M.D. president and CEO of Ocera Therapeutics. "We are encouraged
by these findings which further support our strategy of exploring AST-120
as a platform drug with the potential to address multiple gastrointestinal
and liver diseases."
Patients who suffer from Ulcerative Colitis often require a resection
of the colon to reduce the risk of cancer. A J-pouch is created to collect
stools and the pouch often becomes inflamed, a condition known as
pouchitis, which is associated with diarrhea, abdominal cramps, fever and
dehydration. Pouchitis occurs in up to 40% of patients with a J-pouch and
there are no treatments currently approved for this indication. An
estimated 80,000 patients in the United States suffer from this condition,
which qualifies as Orphan Drug. The current standard of care for pouchitis
includes treatment with antibiotics such as ciprofloxacin and metronidazole
and relapse is common.
In vitro adsorption studies have demonstrated that AST-120 has a high
adsorption capacity for bile acids and bacterial toxins and is expected to
protect the intestinal mucosa of the pouch from inflammation.
AST-120 was in-licensed from Kureha Corporation, Japan in 2005. Ocera
announced last week that it completed enrollment in FHAST1, the Fistula
Healing with AST-120 Phase 3 pivotal trial in Crohn's disease conducted in
North America, Europe and Israel. Ocera also recently initiated
proof-of-concept trials with AST-120 in Irritable Bowel Syndrome and
Hepatic Encephalopathy.
About the Pouchitis Phase 2 Study
The proof-of-concept study conducted under investigator IND at
Cleveland Clinic is evaluating 20 patients with active pouchitis treated
with open label AST-120, 2 grams tid. The Primary efficacy endpoint is
remission as defined by a Pouchitis Disease Activity Index (PDAI) less than
7 points which includes clinical, endoscopy and histology scores. Secondary
endpoints include safety, clinical response measured by a decrease of PDAI
of a least three points and Global Quality of Life score.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company
focused on the licensing, development and commercialization of proprietary
compounds to treat a broad range of gastrointestinal and liver diseases.
Ocera Therapeutics is based in San Diego and is pursuing the development of
AST-120 in Crohn's disease and other gastrointestinal and liver diseases
including Pouchitis, Hepatic Encephalopathy, Irritable Bowel Syndrome and
Proton Pump Inhibitor-resistant Gastroesophageal Reflux Disease. Ocera
Therapeutics has raised $26.5 million dollars in venture financing from
Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners.
Additional information on the Company can be found at
oceratherapeutics.
For more information on Pouchitis and Inflammatory Bowel Diseases,
visit the Crohn's and Colitis Foundation of America website as
ccfa.
Ocera Therapeutics, Inc.
oceratherapeutics
Комментариев нет:
Отправить комментарий