|
|
PipelineOCR-002OCR-002 is a novel, injectable compound to treat Acute Hepatic Encephalopathy (AHE) in patients with liver cirrhosis and acute liver failure.Ocera in-licensed all assets and technologies around compound UCL-L1V from University College London Business in December 2008. OCR-002 is a compound that is under development based on the licensed technology. Clinical trials will be initiated in 2010 under an IND.
AHE is a reversible neuropsychiatric abnormality observed in patients in acute liver failure or chronic liver cirrhosis. In cirrhosis, metabolic conversion of ammonia to urea in the liver fails. With severe liver impairment, toxic substances that are normally removed by the liver, such as ammonia, accumulate in the blood. This can cause cerebral edema, with elevated intracranial pressure, impairing the function of brain cells. Signs and symptoms of AHE include impaired cognition, confusion, and a decreased level of consciousness which can progress to coma and ultimately death. Patients are treated with agents that target ammonia, such as polydisaccharides and antibiotics, but these agents have never been conclusively shown to add incremental benefit over supportive care alone. OCR-002, through its novel mechanism of action, directly lowers circulating blood levels of ammonia by enabling alternate metabolic pathways in organs other than the liver. In preclinical animal models, this novel therapeutic showed an acute and sustained effect in lowering blood ammonia levels. This reduction in ammonia was accompanied by a reduction in brain water and intracranial pressure. OCR-002 is as an injectable formulation which is well suited for the AHE population, and is being developed to provide a safe and effective therapeutic option to treat the life-threatening symptoms.
|
