Megan McLaughlin, Vice President Medicine Development Leader at GSK, discusses data from the GLISTEN phase 3 clinical trial for primary biliary cholangitis (PBC).

 


 

PBC is a chronic, progressive, autoimmune, liver disease in which the bile ducts become inflamed and damaged. This leads to the buildup of bile and causes liver problems such as scarring, cirrhosis, and eventual liver failure. PBC is more common in women. Many people do not have symptoms when they are first diagnosed and may not develop symptoms for several years. Early symptoms may include fatigue, itchy skin (pruritus), and abdominal pain. As the disease progresses, people with PBC may develop weakness, nausea, diarrhea, swelling in the legs and feet, bone and joint pain, jaundice, dark urine, and xanthomas. It is thought to be caused by a combination of genetic susceptibility and environmental triggers.

As evident in the GLISTEN phase 3 trial, one of the most burdensome symptoms of PBC is cholestatic pruritus, an internal itch. The symptom occurs at any stage of disease and is experienced by 90% of patients. Current first line treatments do not reduce the severity of this symptom that greatly impacts quality of life.

Linerixibat is an ileal bile acid transporter (IBAT) inhibitor that targets the root cause of cholestatic pruritus associated with PBC.

The GLISTEN study is a phase 3, ongoing double-blind, randomised, placebo-controlled, trial 

evaluating the efficacy of linerixibat in patients with PBC associated cholestatic pruritus. Recent data has revealed that primary endpoints of the study have been met. These include improvement in itch demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks compared to placebo.

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To learn more about PBC and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-auto-inflammatory-disorders/