Linerixibat for treating pruritus associated with primary biliary cholangitis

Linerixibat is in clinical development for the treatment of primary biliary cholangitis (PBC). PBC is a chronic autoimmune disease where bile (digestive fluid) flow from the liver is disrupted (i.e., cholestasis), resulting in excess bile acids in circulation. Cholestatic pruritus is an itch which is internal and cannot be relieved by scratching. The cause of pruritus in PBC is unclear but it is thought that these circulating bile acids have a role. Pruritus is debilitating and can cause fatigue, sleep disturbance, suicidal ideation and in some cases, a need for a liver transplant in the absence of liver failure. The cause of PBC is unknown but immune, autoimmune, environmental, and genetic factors can play a role. There is a significant unmet need in the management of pruritus in PBC with no new pharmacological therapies approved since the 1960s.