GSK Shares Promising Phase 3 Results for Linerixibat in PBC Itch

GSK has announced encouraging findings from its phase 3 GLISTEN trial concerning linerixibat, an investigational oral medication targeting the rare autoimmune liver disorder known as primary biliary cholangitis (PBC). This condition leads to relentless itching, or cholestatic pruritus, significantly impacting patients' lives by causing sleep disturbances, fatigue, and a diminished quality of life.

The GLISTEN study focused on adult PBC patients suffering from this debilitating itch. During the European Association for the Study of the Liver (EASL) Congress, GSK presented data showing that linerixibat had a marked effect in alleviating itch compared to a placebo over a period of 24 weeks. Specifically, patients receiving linerixibat reported an average improvement of 0.72 points on a ten-point scale assessing the worst itch they experienced, thus fulfilling the primary goal of the trial.

In addition to the primary outcome, the study also achieved key secondary objectives. Notably, significant itch relief was observed by the second week of treatment. Furthermore, linerixibat was linked to improvements in sleep disturbances caused by itching, with 56% of participants experiencing a clinically meaningful reduction in itch, defined as at least a three-point drop on the itch severity scale, compared to 43% in the placebo group by the end of 24 weeks.

PBC is a chronic condition that is expected to impact approximately 510,000 individuals worldwide by 2030. This disease leads to irreversible liver scarring and bile duct damage. It predominantly affects women and is often accompanied by fatigue and joint pain. The itchy sensation can manifest at any stage of PBC and affects up to 90% of patients to varying degrees of severity.

Linerixibat functions by inhibiting the reuptake of bile acids and has received orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency for the treatment of PBC-related cholestatic pruritus. This designation is typically granted to drugs that show promise for treating rare diseases, offering benefits such as reduced regulatory fees and extended market exclusivity.

Kaivan Khavandi, GSK's senior vice president and global head of respiratory, immunology, and inflammation research and development, highlighted the significance of these findings. He noted that the persistent itch associated with PBC affects most patients, impacting their sleep, mental health, and overall quality of life. With linerixibat, there is a potential to address the significant unmet need related to itch and its associated sleep disruptions, which are crucial for patient well-being but have often been under-treated historically.

In summary, the phase 3 GLISTEN trial results offer hope for those living with the chronic and severe symptoms of PBC. If approved, linerixibat could provide much-needed relief for patients, improving not only their physical symptoms but also their overall quality of life. As a result, these findings mark a promising advancement in the treatment of this challenging condition.