Ocera Therapeutics, a biopharmaceutical company, has reported positive data from its Phase II study of AST-120 for the treatment of patients with low-grade hepatic encephalopathy.
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 IIb study of AST-120 in patients with mild hepatic encephalopathy (MHE).
The Phase IIa study randomly assigned 47 patients with West Haven scale (WHS) grade 1-2 hepatic encephalopathy to four weeks of treatment with either AST-120 2gm sachets (A) QID or lactulose (L) titrated to bowel movements.
Approximately 41 patients were evaluable (n=21 A, 20 L) and six were excluded (n=3 L: non-compliance, n=3 A: other causes). Treatment response by WHS at week four was similar between treatment groups (38.1% versus 35%, A versus 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, the company said.
The Astute trial is a Phase II multi-site, randomized, double-blind, placebo-controlled eight-week study in up to 150 patients with MHE. Patients will be evaluated on neurocognitive improvement at the end of the study, defined as the change in the global summary score of the RBANS or repeatable battery for the assessment of neuropsychological status.
Scott Harris, chief medical officer of Ocera, said: The Astute trial will use a battery of neuropsychometric tests to assess the efficacy of AST-120 in an MHE population. Up to 60% of patients with cirrhosis have MHE and impaired neurocognitive function, a condition for which no drugs are approved.