Ocera Initiates Phase 2a Study with Oral OCR-002 in Patients with Cirrhosis
01 Junho 2017 - 10:05AM
Ocera Therapeutics, Inc. (NASDAQ:OCRX), today announced the dosing
of the first patients in Part Two of a Phase1/Phase 2a clinical
trial of oral OCR-002 (ornithine phenylacetate). Oral OCR-002 is a
validated ammonia scavenger in development for use as a step-down
therapy and for chronic use to maintain remission of hepatic
encephalopathy (HE), a neurocognitive disorder associated with
serious liver disease.
The Phase 2a portion of the trial is an open-label,
multiple-dose, randomized, 3-period crossover study. It is designed
to evaluate the steady-state pharmacokinetics and pharmacodynamics
of three times daily administration of three daily dose regimens,
6, 12 and 21 grams, of OCR-002 tablets in 18 patients with
Child-Pugh1 B cirrhosis. We expect to complete the trial and report
top-line results by the end of 2017.
“Advancing oral OCR-002 into Phase 2a marks another significant
milestone in the progression of our pipeline and programs for
orphan and other serious liver diseases,” said Linda Grais, Chief
Executive Officer of Ocera.
“Patients with cirrhosis continue to have significant
breakthrough episodes of HE, even with current standard of care for
HE prevention. We are developing an oral formulation to address
this need. Our initial focus will be as a step-down therapy for
patients following hospitalization for an acute episode of overt
HE, in order to prevent re-hospitalization and relapse of HE.”
About the Part1/Phase 1 Orally-Available OCR-002
Study
The Phase 1 trial was an open-label, crossover study to
determine the pharmacokinetics and the absolute oral
bioavailability of OCR-002 in patients with Child-Pugh1 A and C
cirrhosis. The study evaluated a single 5g dose of IV OCR-002, and
single 5g doses of a liquid oral solution of OCR-002 administered
under various fasted and fed conditions.
Summary of Key Findings:
- OCR-002 was observed to be safe and well-tolerated across all
treatment arms in the study.
- OCR-002 demonstrated absolute oral bioavailability of greater
than 95% in the fasted state.
- Dosing under fed conditions showed a beneficial food
effect.
- A well-characterized pharmacokinetic profile was
established.
About Hepatic Encephalopathy
Hepatic encephalopathy is a debilitating and progressive
complication of liver cirrhosis or liver failure, marked by mental
changes including confusion, impaired motor skills, disorientation,
and in its more severe form, stupor, coma and even 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 in patients with acute liver
failure and acute-on-chronic liver disease. For additional
information, please see www.ocerainc.com.
Ocera's HE clinical development efforts also include a recently
completed Phase 2b clinical trial, STOP-HE, which evaluated the
safety and efficacy of intravenously-administered (IV) OCR-002 in
resolving neurocognitive symptoms of acute HE in hospitalized
patients with elevated ammonia. The Company is preparing to meet
with the FDA later this year to review the IV OCR-002 program and
discuss potential development paths forward. 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
OCR-002 clinical development program, including but not limited to
the potential benefits of OCR-002 to help patients with hepatic
encephalopathy, the timing of our study results, our ability to
identify a development path forward for IV OCR-002, and the timing
and nature of our future clinical development plans. 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 the risk that we may need to conduct one
or more additional studies in light of the fact our Phase 2b trial
did not meet its clinical endpoints, including related cost and
timing issues associated with future studies, if any, our ability
to raise sufficient capital or consummate other strategic
transactions to enable the continued development of OCR-002, and
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, 2016 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.
1Child-Pugh Scoring is a clinically relevant method of assessing
the severity of liver impairment in patients with cirrhosis. A
score, ranging from 5 (least severe) to 15 (most severe), is
calculated by totaling the scores of five discrete variables: serum
bilirubin, serum albumin, prothrombin time, ascites and
encephalopathy. Scores of 5-6 are classified as Child-Pugh A (well
compensated disease); scores of 10-15 are classified as Child-Pugh
B (disease with significant functional compromise); and scores of
10-15 are classified as Child-Pugh C (decompensated liver
disease).
Susan SharpeOcera Therapeutics, Inc.contact@ocerainc.com
919-328-1109
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