PALO ALTO, Calif., Jan. 8, 2014 (GLOBE NEWSWIRE) -- Ocera Therapeutics (Nasdaq:OCRX) today announced enrollment of the first patient in its multi-center Phase 2b study, the "STOP-HE" or OCR002-HE209 trial. This study is evaluating the efficacy, safety and pharmacokinetics of OCR-002, or ornithine phenylacetate, in hospitalized patients with liver cirrhosis and an acute episode of hepatic encephalopathy (HE). HE is a serious complication of liver failure and decompensated cirrhosis in the setting of chronic liver disease, where elevation of ammonia concentration in the blood and brain can lead to deterioration of neurocognitive function, ranging from subtle abnormalities to frank (overt) disorientation, stupor, coma and death. OCR-002 is a novel molecule, an ammonia scavenger which is intended to rapidly reduce the concentration of ammonia in the blood when administered as a continuous intravenous infusion. OCR-002 has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant HE in patients with acute liver failure or acute on chronic liver disease.
"HE is a serious disorder that leads to approximately 150,000 hospitalizations per year in the United States and for which the best available treatments are still suboptimal. We need better and more effective treatments," said Robert Brown M.D., Frank Cardile professor of medicine and pediatrics and director, Center for Liver Disease and Transplantation, Columbia University and a principal investigator in the Ocera Phase 2b study.
The study is a randomized double-blind, controlled study of OCR-002 plus current standard of care versus standard of care alone. The study will enroll 200 patients at approximately 40 centers in the United States and Canada. The trial will assess time to achievement of meaningful improvement in HE symptoms. Ocera anticipates completing the study in early 2015."We are excited to begin enrolling patients in the Phase 2b study," said Linda Grais, M.D., J.D., CEO of Ocera. "The number of hospitalizations for HE has been increasing steadily over the past decade and we are eager to help these seriously ill patients."