GSK has announced positive results from its Phase 3 trial of linerixibat, an investigational drug aimed at reducing itch in patients with primary biliary cholangitis (PBC). The trial met its primary endpoint, demonstrating a statistically significant reduction in pruritus, a common and distressing symptom of PBC.
The late-stage trial's success positions GSK to pursue regulatory filings for linerixibat, potentially providing a new therapeutic avenue for PBC patients suffering from persistent itch. PBC is a rare, chronic liver disease characterized by the progressive destruction of the bile ducts, leading to cholestasis and liver damage. Pruritus affects a significant proportion of PBC patients, severely impacting their quality of life.
"The results from this Phase 3 trial are encouraging, highlighting the potential of linerixibat to alleviate the burden of itch in individuals with PBC," said a lead investigator in the study. "Current treatment options are often inadequate, leaving many patients with persistent and debilitating pruritus."
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor. The drug works by reducing the reabsorption of bile acids in the small intestine, leading to decreased bile acid levels in the circulation and potentially reducing itch. The Phase 3 trial was a randomized, double-blind, placebo-controlled study that enrolled patients with PBC who experienced moderate-to-severe pruritus despite being on ursodeoxycholic acid (UDCA), the standard first-line treatment for PBC.
The study evaluated the efficacy and safety of linerixibat compared to placebo over a specified treatment period. The primary endpoint was the change from baseline in the pruritus score, as measured by a validated itch assessment scale. Secondary endpoints included measures of liver function and patient-reported outcomes related to quality of life.
Detailed results from the Phase 3 trial will be presented at an upcoming medical conference and submitted for publication in a peer-reviewed journal. GSK plans to initiate regulatory submissions for linerixibat in major markets based on these positive findings.
