Data establish ammonia-lowering properties of orally-administered OCR-002 in preclinical model of cirrhosis
Data highlight CNS neurochemical changes occurring in preclinical model of hepatic encephalopathy which are normalized with OCR-002
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., April 15, 2016 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ: OCRX ), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that data from two investigator-sponsored preclinical studies of Ocera’s ammonia scavenger, ornithine phenylacetate (OCR-002), will be presented today in poster sessions at The International Liver Congress™ of the European Association for the Study of the Liver (EASL 2016) being held in Barcelona, Spain.
One study investigated the effects of orally-administered OCR-002 in bile duct ligated (BDL) rats, a model of cirrhosis, and sham-operated rats. In cirrhotic rats treated with OCR-002 compared to untreated rats, OCR-002 was shown to:
- Lower plasma ammonia
- Preserve muscle mass and function
- Improve locomotor activity
- Protect against the development of brain edema; and
- Improve body weight gain Beneficial Effects of Ornithine Phenylacetate to Attenuate Muscle Mass Loss and to Prevent Hepatic Encephalopathy in Experimental Cirrhosis (poster FRI-007) Author: C. Rose CRCHUM, Université de Montréal
In a second study, BDL rats and normal rats fed a high ammonia diet were each shown to have elevated plasma ammonia and alterations in brain neurochemistry via interrogation of ex vivo cortical brain slices. BDL rats treated with OCR-002 compared to both untreated BDL rats and sham rats fed a high ammonia diet demonstrated lower plasma ammonia, and in cortical brain slices, demonstrated recovery of lactate release and normalization of glutamate release in cortical neurons.
Alterations in the CNS Hemichannel Function and Neurochemical Phenotype in the Pathogenesis of Hepatic Encephalopathy (poster FRI-002) Lead Author: A Hadjihambi, University College London
The poster abstracts can be accessed by poster number via the congress website at: https://events.easl.eu/EventProgramme/ILC2016/POSTER.aspx .
“These two exciting preclinical studies continue to validate the potential utility of OCR-002 to reduce ammonia and to address some of the systemic complications of cirrhosis for which current treatments are lacking or ineffective,” said Linda Grais, M.D., Ocera’s Chief Executive Officer. “We now also have preclinical evidence that orally-administered OCR-002 lowers ammonia, an important step in the development of a chronic therapy for hepatic encephalopathy (HE) prevention.
“Further, the data support earlier findings that OCR-002 may have the potential to reduce brain edema, a characteristic and complicating factor of HE, and also to protect against the development of muscle mass loss associated with chronic liver disease. The new insights learned about neurochemical changes in the brain provide an opportunity for further research with OCR-002 to treat this debilitating condition.”
About OCR-002 IV and Oral Formulations
OCR-002 is in development as both an intravenous formulation as a potential treatment for hospitalized patients with acute HE, and as an oral formulation to potentially provide a chronic use option to maintain remission of HE in patients with cirrhosis. The IV formulation is being evaluated in STOP-HE, a Phase 2b clinical trial of OCR-002 in patients with acute hepatic encephalopathy. The Company plans to complete enrollment in the STOP-HE clinical trial in the fourth quarter of 2016. In 2015, Ocera announced positive results from a pilot Phase 1 clinical trial of orally-available pilot formulations of OCR-002 for the prevention of HE in chronic cirrhotic patients. The Company plans to initiate an additional Phase 1 clinical trial of oral OCR-002 and report findings by the end of 2016.
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 (HE) in patients with acute liver failure and acute-on-chronic liver disease. 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 ability of OCR-002 to reduce ammonia levels, the potential benefits of OCR-002 to help patients with hepatic encephalopathy and other liver diseases, the timing of clinical and enrollment milestones, and the timing 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. OCRX-G
Susan Sharpe Ocera Therapeutics, Inc. contact@ocerainc.com 919-328-1109
