Ocera Therapeutics Announces Late-Breaker Abstract Accepted for Presentation at the AASLD Liver Meeting 2016
October 24 2016 - 9:05AM
Ocera Therapeutics, Inc. (NASDAQ:OCRX), today announced that
clinical data from STOP-ALF, a Phase 2a clinical trial to evaluate
the
Safety and
Tolerability of
Ornithine
Phenylacetate (OCR-002)
in patients with
Acute
Liver
Failure, will be presented in the late-breaking
poster session at The Liver Meeting® 2016, the 67th Annual
Meeting of the American Association for the Study of Liver Disease
(AASLD), being held on November 11-15, 2016, in Boston,
Massachusetts.
Key findings of this safety study reflected in the abstract
include the following:
- No drug-related serious adverse events observed; all doses
well-tolerated
- Therapeutic serum levels of phenylacetate (PAA) were achieved
at infusion rates of OCR-002 20g/24h
- Therapeutic PAA levels appeared to result in considerable
ammonia excretion in urine as phenylacetylglutamine (PAGN), the end
product by which PAA clears the neurotoxin ammonia, even in
patients with non-oliguric renal failure
“Hyperammonemia can lead to cerebral edema, and remains a
significant cause of morbidity and mortality in patients with acute
liver failure,” commented William M. Lee, M.D., principal
investigator of the study. “We are very excited by the results of
this safety trial and hope further studies can be conducted to
examine the potential for OCR-002 to help clear the high ammonia
levels, and improve the outcome of these patients.”
“We are very pleased this important study has been completed,”
said Stan Bukofzer, M.D., Chief Medical Officer of Ocera. “In light
of the safety profile and tolerability of OCR-002 in this very ill
patient population, we believe it could have potential in the
management of Acute Liver Failure.”
Additional details including the presentation abstract can be
found on the AASLD website by clicking this link.
About STOP-ALF
The Phase 2a study was a multi-center, open-label study,
conducted in two cohorts of patients diagnosed with acute liver
failure. Patients were treated pursuant to one of four escalating
dosing regimens of intravenously-administered OCR-002, an ammonia
scavenger, which were advanced only after safety and certain
pharmacokinetic data were reviewed. Cohort 1 was comprised of
affected patients with minimal renal dysfunction (defined as serum
creatinine ≤ 1.5 mg/dL and mean arterial pressure of > 65 mm
Hg). Cohort 2 included affected patients with compromised renal
function (defined as serum creatinine > 1.5 mg/dL and < 10
mg/dL with mean arterial pressure of > 65 mm Hg). Dose levels
within the four regimens ranged from approximately 3.33 g/24h to 20
g/24h for up to 5 treatment days. 36 of 47 patients enrolled are
considered evaluable having completed at least 72 hours of
treatment. The study, ClinicalTrials.gov: NCT00518440, was
conducted by the Acute Liver Failure Study Group, grant number
U-01-58369, an NIH-sponsored network of university tertiary care
liver transplant sites, with support and supply of study medication
from Ocera.
About Acute Liver Failure (ALF)
Acute liver failure is a rare syndrome with a significant
mortality rate affecting an estimated 2,000 previously healthy
individuals annually in the U.S. ALF is a rapid deterioration of
liver function, often due to acetaminophen and idiosyncratic drug
reactions, resulting in the liver’s inability to clear the
circulating toxin Ammonia, which can lead to cerebral edema,
intracranial hypertension, brainstem herniation and death.
About Ocera
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical
company focused on the development and commercialization of OCR-002
(ornithine phenylacetate) in both intravenous and oral
formulations. OCR-002 is an ammonia scavenger and has been granted
orphan drug designation and Fast Track status by the U.S. Food and
Drug Administration (FDA) for the treatment of hyperammonemia and
resultant hepatic encephalopathy (HE) in patients with acute liver
failure and acute-on-chronic liver disease.
Ocera's HE clinical development efforts include an ongoing Phase
2b clinical trial, STOP-HE, which is evaluating the safety and
efficacy of intravenously-administered OCR-002 in resolving
neurocognitive symptoms of acute HE in hospitalized patients with
elevated ammonia. The Company expects to complete enrollment in the
STOP-HE trial in the fourth quarter of 2016 with top-line data to
be published soon thereafter.
Concurrent with STOP-HE, Ocera is evaluating orally-available
OCR-002 in a Phase 1 study in patients with cirrhosis as a chronic
use option to maintain remission of HE. Results of part one of this
study are expected to be published by the end of 2016 with part two
expected to commence in the first half of 2017. For additional
information, please see www.ocerainc.com.
Forward-Looking Statements
This press release contains "forward-looking" statements,
including, without limitation, all statements related to the
clinical development of OCR-002, including but not limited to the
potential benefits of OCR-002 to help patients with acute liver
failure or hepatic encephalopathy, the timing of clinical and
enrollment milestones, and the timing of completion of enrollment
and availability of study data. Any statements contained in this
press release that are not statements of historical fact may be
deemed to be forward-looking statements. Words such as "believe,"
"expected," "hope," "plan," "potential," "will" and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Ocera's current
expectations. Forward-looking statements involve risks and
uncertainties and Ocera's actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, including those risks and uncertainties discussed
under the heading "Risk Factors" in Ocera's Annual Report on
Form 10-K for the year ended December 31, 2015 and subsequent
filings with the SEC. All information in this press release is
as of the date of the release, and Ocera undertakes no duty to
update this information unless required by law.
The content of this announcement is the sole responsibility of
the authors and does not necessarily represent the official views
or imply endorsement of the NIH.
OCRX-G
Susan SharpeOcera Therapeutics,
Inc.contact@ocerainc.com919-328-1109
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