Primary biliary cholangitis (PBC) Disease Pipeline Drugs Assessment Clinical Trails Analysis, Player Profiles, Collaborations, Key Targets, Geographic Focus, and Data Publications, 2019 - 2030

Primary Biliary Cholangitis is a chronic, presumable autoimmune liver diseases which further leads to progressive cholestasis and often end-stage liver diseases. This disease was formerly called as Primary Biliary Cirrhosis. PBC is the most common disease of women. Symptoms of PBC includes fatigue, pruritus, right upper quadrant discomfort, hepatomegaly, hyperpigmentation, jaundice, splenomegaly, xerophthalmia, kayser-fleischer rings etc.

Generally 25% of patients with PBC can be diagnosed by routine blood evaluation. Diagnosis of PBC includes evaluation of levels of ceruloplasmin, bile acids, serum hyaluronate, determination of presence of antimitochondrial antibodies (AMAs) in serum by ELISA and Complement Fixation Test. Imaging studies of PBC is done by Ultrasonography, CT Scan or MRI.

Ursodeoxycholic acid (UDCA) is the main treatment for people with PBC and Obeticholic acid (OCA) is a new treatment that works by improving bile flow and reducing inflammation. Medications like antibiotics can be given to treat other symptoms of PBC like pruritis. If the liver is completely damaged then Liver transplantation is recommended.

Key Developments:

• In October 2017, NGM biopharmaceuticals initiated phase II expansion trial for Non-Alcoholic Steatohepatitis. It has completed the Phase 2a proof-of-concept trial for 28 days in patients with primary biliary cholangitis, in which the results demonstrated that there is a significant reduction of ALP (Biochemical market of liver health) along with no significant worsening of pruritus with 28 days treatment of NGM282.
• In October 2017, Gilead Sciences completed Phase 2 studies of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH) , the results determines that the higher dose of GS-0976 (20 mg taken orally once daily) when administered for 12 weeks was associated with statistically significant reductions in hepatic steatosis (buildup of fat in the liver) and a noninvasive marker of fibrosis (TIMP-1)