When the liver fails, the brain fails
An estimated 30-35 million people suffer from chronic liver disease in the U.S. alone, stemming from factors such as alcohol use, hepatitis, drug exposure, autoimmune diseases, nonalcoholic steatohepatitis (NASH), fatty liver, diabetes and obesity.
Of those, approximately 5.5 million suffer from liver cirrhosis, a condition in which scar tissue replaces healthy liver tissue, and normal liver function is impaired. As the liver loses its ability to remove toxic substances from the blood, there is an accumulation of such toxins, particularly ammonia. This accumulation of ammonia in the blood impairs brain cell function, and can lead to a neuropsychiatric condition called *hepatic encephalopathy, or HE.
HE is marked by impaired cognition and motor skills, and decreased levels of consciousness. If it progresses untreated, HE can lead to coma and death due to brain swelling. Currently, there are no drug treatments for HE that can be given intravenously (IV) to hospitalized patients with acute HE. Ocera believes there is a significant unmet need for an intravenous drug that can rapidly and safely treat patients with acute HE, and is developing IV OCR-002 to address this problem.
In addition, OCR-002 is being developed as an oral formulation as a potential for step-down therapy and for chronic use to prevent recurrences of hepatic encephalopathy.