GSK announced positive headline results in a global phase 3 trial evaluating its investigational targeted inhibitor of the ileal bile acid transporter (IBAT) in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease.
The GLISTEN trial met its primary endpoint, with the IBAT, linerixibat, resulting in an improvement in itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo. The trial recruited PBC patients with moderate to severe itch, who were receiving stable doses of guideline-suggested therapies for pruritus, or were treatment naïve, or had been previously treated.
PBC is a rare disease of the bile ducts that primarily affects women and can cause liver damage and possible liver failure if untreated. One of the most common symptoms is constant, relentless itching or skin-crawling sensations. If approved, linerixibat has the potential to be the first global therapy specifically developed to treat itch in PBC.
Linerixibat is a minimally absorbed small molecule inhibitor of IBAT administered as an oral tablet. By blocking resorption of bile acids in the small intestine, linerixibat reduces pruritic bile acids in circulation. The FDA has granted orphan drug designation to linerixibat for the treatment of PBC and associated cholestatic pruritus.