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Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases
Date:9/26/2013

ssive Familial Intrahepatic Cholestasis

PFIC is a rare genetic disorder that causes progressive liver disease, which typically leads to liver failure. PFIC is inherited in an autosomal recessive way, meaning that there are mutations in both copies of the gene in order for the disease to be present. The disease is estimated to affect one in every 50,000 to 100,000 people worldwide. In people with PFIC, liver cells are less able to secrete bile due to mutations in proteins that control bile homeostasis. The resulting build up of bile in liver cells causes severe liver disease in affected individuals. Three types of PFIC have been identified.

About Primary Biliary Cirrhosis

PBC is thought to be caused by an autoimmune process. The disease affects women more often than men, and is usually diagnosed between the ages of 40 and 60. In this chronic condition the bile ducts in the liver become inflamed and are slowly destroyed. Bile duct damage results in accumulation of bile acids and other harmful substances in the circulation that cause injury to the liver. In patients with PBC the liver disease can progress to irreversible cirrhosis and liver failure.

About Primary Sclerosing Cholangitis

PSC is a disease that causes chronic inflammation and subsequent scarring of the bile ducts both inside and outside the liver. The blockage of the bile ducts prevents bile from being transported to the small intestines and gall bladder. The accumulation of bile in the liver leads to progressive liver damage, and eventually, liver failure. PSC affects approximately one in 10,000 people, and for reasons that are unknown, it impacts men twice as often as women. Liver transplant is the only known cure for PSC, but transplant is typically reserved for patients with severe liver damage.

About LUM001

LUM001 is an inhibitor of the apical sodium-dependent bile acid transporter (ASBT), which recycles intestinal bile acids back into the circulation.
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