Highlights:
GSK's linerixibat candidate shows positive results in Phase III trial for cholestatic pruritus in primary biliary cholangitis (PBC).
The trial met its primary endpoint with a statistically significant improvement in itch relief over 24 weeks compared to placebo.
Linerixibat could become the first global therapy to treat persistent itch in PBC patients.
GSK (LSE:GSK) has announced promising results from the GLISTEN Phase III trial of its investigational drug, linerixibat, for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC). The trial, which involved adults suffering from the "relentless itch" linked to this rare autoimmune liver disease, demonstrated a statistically significant improvement in itch reduction over a 24-week period when compared to a placebo.
Linerixibat, which works as a targeted inhibitor of the ileal bile acid transporter, has the potential to become the first global treatment specifically designed to address the chronic and debilitating symptom of itch in PBC patients. The condition, which impacts the liver and often leads to intense and persistent itching, can severely affect a patient’s quality of life.
Kaivan Khavandi, a representative from GSK, emphasized the significance of these results, noting that the positive data highlight the potential of linerixibat to provide much-needed relief to PBC patients suffering from persistent pruritus. The company views this development as a key step forward in addressing a significant unmet need in the treatment of PBC, where few therapeutic options exist.
Despite the positive trial results, GSK shares saw a slight decline of 0.31% at 1,306.0p as of 0920 GMT on Tuesday. The results from the Phase III GLISTEN trial, however, represent a major milestone for GSK, positioning linerixibat as a potential first-line treatment for cholestatic pruritus in PBC, a critical symptom that significantly impacts patient well-being.
These findings also underscore GSK’s continued focus on advancing therapies for rare and complex conditions, reinforcing the company’s commitment to addressing unmet medical needs in areas such as liver disease.