Ocera Therapeutics Inc (OCRX) Shares Rally Amid Positive Preclinical Data In NAFLD/NASH

Ocera Therapeutics Inc (NASDAQ:OCRX) shareholders are enjoying a surprise rally in the stock today, after the drug maker announced that its clinical candidate OCR-002 prevented progression of fibrosis in preclinical model of nonalcoholic fatty liver disease (NAFLD).

The study investigated the effect of OCR-002 in a NAFLD rat model in which animals were fed a High Fat and High Cholesterol (HFHC) diet for up to 16 weeks. Compared to normal rats, NAFLD rats showed a significant increase in ammonia (p<0.05), as well as increased blood levels of cholesterol, ALT and AST. The NAFLD rats treated with OCR-002 showed significant reduction in the progression of fibrosis compared to untreated NAFLD rats. Moreover, OCR-002 substantially reduced:

  • Liver / Body weight ratio
  • Hepatic lipid content, and
  • Hepatic collagen

In prior clinical trials, OCR-002 has been demonstrated to work in humans by conjugating its phenylacetate moiety with glutamine (which contains ammonia) to form phenylacetylglutamine (PAGN), which is then excreted through the kidneys. In some animal models, phenylacetate also combined with glycine to form phenylacetylglycine (PAG), also excreted in the urine. In the OCR-002 treated NAFLD rats, high levels of PAGN and PAG were observed, indicating the mechanism of action of OCR-002.

“We are again excited to see evidence of OCR-002’s ability to target ammonia in hyperammonemia-related indications that in turn drives clinical improvement,” said Stan Bukofzer, M.D., Ocera’s Chief Medical Officer. “In our recently completed STOP-HE Phase 2b study in patients hospitalized with acute hepatic encephalopathy (HE), OCR-002 demonstrated a highly statistically significant correlation between rapid reduction of the neurotoxin ammonia, and improvement in the neurocognitive symptoms of HE (p=0.0006). The preclinical study to be presented at EASL demonstrated the impact of OCR-002 in a NAFLD model and its corresponding ability to significantly reduce the progression of fibrosis, adding to our belief that OCR-002 may have broad potential to treat ammonia-driven complications.”

Professor Rajiv Jalan, M.B.B.S, M.D. Ph.D., whose group performed the research at UCL said, “The data provide further proof that ammonia is more than just a neurotoxin and establishes ammonia as a therapeutic target for the prevention of progression of non-alcoholic fatty liver disease. As OCR-002 is already in advanced stages of clinical development, these data can readily be translated into real benefits for patients with appropriate clinical trials.”

The data will be presented in a poster session at The International Liver Congress™ of the European Association for the Study of the Liver (EASL 2017) in Amsterdam, The Netherlands, on Thursday, April 20, 2017.

On the ratings front, OCRX has been the subject of a number of recent research reports. In a report issued on March 15, H.C. Wainwright analyst Ed Arce reiterated a Buy rating on OCRX, with a price target of $4.00, which implies an upside of 236% from current levels. On March 10, Aegis Capital Corp.’s Difei Yang reiterated a Buy rating on the stock and has a price target of $3.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ed Arce and Difei Yang have a yearly average return of 30.2% and 7.5% respectively. Arce has a success rate of 49% and is ranked #103 out of 4560 analysts, while Yang has a success rate of 44% and is ranked #614.

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company. It engages in development and commercialization of OCR-002 (ornithine phenylacetate0 in intravenous and oral formulations.


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