Biotech Values

[DewDiligence]

OCRX’s PR on STOP-HE phase-2b trial:

http://finance.yahoo.com/news/ocera-announces-top-line-results-120000503.html

Ocera Therapeutics, Inc…today announced top-line results from its exploratory STOP-HE Phase 2b Study evaluating the efficacy, safety and tolerability of intravenously-administered Ornithine Phenylacetate (OCR-002) in hospitalized patients with Hepatic Encephalopathy (HE).

Although not statistically significant, OCR-002 demonstrated a 17-hour [median] reduction over placebo (47 versus 64 hours, respectively) for the primary endpoint, which was time to improvement in HE symptoms, p=0.129, hazard ratio 1.25 [i.e. HR=0.80 using the conventional manner of reporting where lower numbers are better].

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 [HR=0.86 using the conventional manner of reporting].

Consistent with its mechanism of action, OCR-002 exhibited a statistically significant 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 [HR=0.59 using the conventional manner of reporting].

Questions on the CC focused on whether STOP-HE can still serve as one of the two required pivotal studies for FDA approval of the IV formulation of OCR-002 as a treatment for acute HE. The company did not give a clear answer, but missing the primary endpoint would seem to make this unlikely.