Ocera Therapeutics Presents Data on AST-120 in Patients With Hepatic Encephalopathy at the European Association for the Study of Liver Disease Annu...( The Company also Initiates the Phase ...)

The Company also Initiates the Phase 2b ASTUTE Clinical Trial for Mild Hepatic Encephalopathy

SAN DIEGO, April 28 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately held biopharmaceutical company, announced that data from its phase 2 study of AST-120 for the treatment of patients with low-grade hepatic encephalopathy was presented April 25th at the 44th Annual Meeting of the European Association for the Study of Liver Disease (EASL) in Copenhagen. The study showed that AST-120 was better tolerated than lactulose, the standard of care in this population, with similar overall efficacy. An improvement on neurocognitive measures was also seen with AST-120. Based on these positive data, Ocera has initiated and dosed their first patient in the ASTUTE study, a phase 2b study of AST-120 in patients with mild hepatic encephalopathy (MHE).

The phase 2a study randomly assigned 47 patients with West Haven Scale (WHS) Grade 1-2 hepatic encephalopathy to 4 weeks of treatment with either AST-120 2g sachets (A) QID or lactulose (L) titrated to bowel movements. Forty-one patients were evaluable (n=21 A, 20 L) and 6 were excluded (n=3 L: non-compliance, n=3 A: other causes). Treatment response by WHS at Week 4 was similar between treatment groups (38.1% vs. 35.0%, A vs. L). AST-120 also produced an improvement in neurocognitive measures. A statistically significant reduction in pruritus, a secondary endpoint of the trial, was seen with AST-120 compared to lactulose. Adverse events related to diarrhea (p = 0.04) and flatulence (p = 0.02) were significantly less in patients treated with AST-120.

The improvement seen in neurocognitive measures is consistent with reports that neuropsychometric testing is required to truly measure deficits and detect changes in neurocognitive functioning in the MHE patient population.

"Patients with mild hepatic encephalopathy often don't comply with lactulose therapy because
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