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Ocera Therapeutics, Inc.
, a clinical stage biopharmaceutical company focused on acute and
chronic orphan liver diseases, today announced successful completion of a
planned interim analysis of its STOP-HE study, a double-blind
placebo-controlled study of OCR-002 in patients with acute hepatic
encephalopathy (HE). The study's independent Data Monitoring Committee (DMC)
reported that the trial is not futile and no drug-related safety signals have
been observed in the study. Based on the DMC's recommendation, Ocera will
continue the STOP-HE study and will increase target enrollment from 140
patients to approximately 230 patients. The Company remains blinded to data
reviewed by the DMC in the interim analysis.
"We are encouraged that these early data suggest a promising treatment effect
with OCR-002 and a reduction in time to recovery for patients with acute
hepatic encephalopathy," said Linda S. Grais, M.D., Chief Executive Officer of
Ocera. "While the new enrollment target will extend our timelines, we believe
that this will enhance the likelihood of achieving a positive result at the
end of the study. Treatment options for these severely ill patients are
sub-optimal. We believe OCR-002 may help these patients recover more rapidly
from acute episodes of HE, as well as provide pharmacoeconomic benefit to
hospitals, payors and the healthcare system. With the new enrollment target,
we anticipate completing this trial in the second half of 2016."
HE is a serious, rare, progressive and episodic complication of liver
cirrhosis, or liver failure, marked by mental changes including confusion,
impaired motor skills, disorientation in time and space, and in its more
severe form, stupor, coma and even death.
"This positive recommendation is important for the advancement of newer
therapies for seriously ill HE patients who are not responding to current
standard of care," commented Jasmohan Bajaj, M.D. Dr. Bajaj, a STOP-HE study
investigator, is a gastroenterologist and transplant hepatologist at Virginia
Commonwealth University and the McGuire Veterans Affairs Medical Center in
Richmond, Virginia. "HE in the acute care setting remains a challenging
clinical condition. OCR-002 is a novel, promising therapeutic option for HE
and we look forward to the speedy completion of this trial."
STOP-HE Study Design
STOP-HE is a placebo-controlled, randomized, double-blind clinical trial
designed to evaluate the safety, pharmacokinetics and efficacy of
intravenously-administered OCR-002 in resolving neurocognitive symptoms of
acute HE in hospitalized cirrhotic patients with elevated ammonia. Either
OCR-002 or placebo is administered to patients intravenously for up to five
days along with standard of care. The OCR-002 arm has been dosed with 20, 15,
or 10 grams over 24 hours based on the patient's degree of liver impairment in
order to normalize drug exposure. The primary efficacy endpoint is time to
meaningful clinical improvement analyzed using a 0.05 level 2-sided log-rank
test of equality of time to event curves with 80% power. The pre-specified
interim reassessment of sample size was conducted to assess the adequacy of
the planned sample size of the study (n=140) to detect a difference between
treatment arms in the median time to improvement. Using a sample size of 140
patients, the estimated median time to improvement was driven by an assumed
response rate of 68% vs. 45% in OCR-002 vs. placebo arms, respectively,
resulting in an approximately 50% faster median time to meaningful clinical
improvement over a five day treatment period.
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