Glaxo's linerixibat misses endpoint in liver disease study but some positives

• GlaxoSmithKline (GSK +1.2%) announces mixed results from a Phase 2 clinical trial, GLIMMER, evaluating linerixibat for the treatment of cholestatic pruritis (severe internal itching believed to be caused by excess circulating bile acids) in patients with primary biliary cholangitis (PBG), a chronic liver disease characterized by the progressive destruction of the bile ducts. The data were presented at The Liver Meeting.
• 147 participants received once-daily 20 mg, 90 mg or 180 mg or 40 mg or 90 mg twice-daily of linerixibat or placebo for 12 weeks. The primary endpoint was the mean change from baseline in a scale called Mean Worst Daily Itch Score.
• The main objective was not achieved in the overall population but three treatment groups (40 mg & 90 mg twice-daily and 180 mg once-daily) showed statistically significant improvements in itch compared to control.
• There was also a statistically significant relative reduction in itch in a subgroup of patients with moderate-to-severe pruritis in the 40 mg twice-daily arm.
• On the safety front, the most common treatment-related adverse events were diarrhea and abdominal pain. The safety profile was considered acceptable to proceed to Phase 3 studies.
• https://seekingalpha.com/news/3636239-glaxos-linerixibat-misses-endpoint-in-liver-disease-study-positives-seen