Ocera Therapeutics Reports Presentation of Two Preclinical Studies Showing Further Support for OCR-002

Ocera Therapeutics, Inc.

, 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."