We are a clinical-stage biopharmaceutical company targeting acute and chronic orphan liver diseases. Our initial focus is the development and commercialization of a clinical product candidate, OCR-002, in both intravenous, or IV, and oral formulations, for the treatment of acute and chronic hepatic encephalopathy, or HE. HE is a serious complication of liver cirrhosis, or liver failure, marked by mental changes including confusion, impaired motor skills, disorientation in time and space, and, in its more severe form, stupor, coma and even death. Although the exact cause of HE is not completely understood, there is growing evidence that elevated ammonia is a primary driver of HE, and that lowering ammonia may be beneficial to patients suffering from HE. Common causes of liver malfunction leading to elevated ammonia levels and HE include alcoholism, viral hepatitis and autoimmune diseases, non-alcoholic steatohepatitis, or NASH, as well as obesity, Type II diabetes, and acetaminophen overdose. It is estimated that there are between 30 to 35 million individuals in the United States with some form of chronic liver disease, of which approximately 5.5 million have cirrhosis. Of these 5.5 million individuals, approximately 1.5 to 2.0 million are at risk for developing HE. Approximately 200,000 of these individuals are hospitalized with overt HE per year in the United States. OCR-002 is a novel molecule, ornithine phenylacetate, which functions as an ammonia scavenger and which we believe is the only direct ammonia scavenger currently in clinical development for the treatment and prevention of HE. In January 2017, we announced the top-line results from our exploratory study, STOP-HE, a Phase 2b clinical trial evaluating the safety, tolerability and efficacy of intravenously-administered OCR-002 in hospitalized patients with HE. The data showed that OCR-002 was both safe and well-tolerated at all dose levels evaluated. Although not statistically significant, OCR-002 demonstrated a 17-hour reduction over placebo (47 versus 64 hours, respectively) for the primary endpoint, which was median time to improvement in HE symptoms, p=0.129, hazard ratio 1.25. In addition, OCR-002 demonstrated a 15-hour reduction over placebo (87 versus 102 hours, respectively) for the secondary endpoint, which was median time to complete response in HE symptoms, p=0.361, hazard ratio 1.16. Notwithstanding that the clinical endpoints did not reach statistical significance, the patients at the higher doses (15 and 20 grams) had greater complete response rates compared to the patients on the lowest dose (10 grams) and those on placebo. In addition, consistent with its mechanism of action and the data we observed in pre-clinical studies, OCR-002 exhibited a statistically significant ammonia reduction over placebo for the study’s pre-specified exploratory endpoint which was time to achieve normal plasma ammonia levels, p=0.028, hazard ratio 1.69.
Company profile
Website
CEO
Linda S. Grais
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
Former names
Tranzyme Inc
SEC CIK
Corporate docs
IRS number
631192270
Latest filings (excl ownership)
15-12B
Securities registration termination
21 Dec 17
EFFECT
Notice of effectiveness
13 Dec 17
EFFECT
Notice of effectiveness
13 Dec 17
EFFECT
Notice of effectiveness
13 Dec 17
25-NSE
Exchange delisting
11 Dec 17
8-K
Termination of a Material Definitive Agreement
11 Dec 17
POS AM
Prospectus update (post-effective amendment)
11 Dec 17
POS AM
Prospectus update (post-effective amendment)
11 Dec 17
POS AM
Prospectus update (post-effective amendment)
11 Dec 17
S-8 POS
Registration of securities for employees (post-effective amendment)
11 Dec 17
Latest ownership filings
SC 13G/A
Ocera Therapeutics, Inc.
14 Feb 18
SC 13G/A
Ocera Therapeutics, Inc.
14 Feb 18
SC 13D/A
Ocera Therapeutics, Inc.
21 Dec 17
SC 13D/A
Ocera Therapeutics, Inc.
14 Dec 17
4
Brian K Halak
13 Dec 17
4
Brian K Halak
13 Dec 17
4
BRIAN H DOVEY
13 Dec 17
4
BRIAN H DOVEY
13 Dec 17
4
Brian K Halak
13 Dec 17
4
Willard H Dere
11 Dec 17
Institutional ownership, Q3 2019
13F holders | Current |
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Total holders | 0 |
Opened positions | 0 |
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Reduced positions | 0 |
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Total value | 0.00 |
Total shares | 0.00 |
Total puts | 0.00 |
Total calls | 0.00 |
Total put/call ratio | – |
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