Intercept announces new findings from long-term extension of POISE trial

Intercept Pharmaceuticals, a biopharmaceutical company and wholly-owned subsidiary of Alfasigma, announced new data from a sub-analysis of the landmark Phase 3 POISE trial evaluating the impact of obeticholic acid on achievement of gamma-glutamyl transferase less than3.2upper limit of normal and alkaline phosphatase less than1.5ULN for the treatment of primary biliary cholangitis. This analysis suggests OCA’s potential to reduce GGT, in addition to the well-known effects on ALP levels, below the biochemical thresholds that are prognostic for worsening clinical outcomes. These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ The Liver Meeting in Boston. Hepatocyte injury causes GGT to be released into the blood. Elevated GGT in the setting of elevated ALP and other liver enzyme abnormalities is a marker for hepatobiliary disorder. The goal of this sub-analysis was to evaluate the proportion of patients receiving OCA who achieved and sustained GGT less than3.2ULN and ALP less than1.5ULN. Results include: In the double-blind intent-to-treat population, the proportion of responders was significantly greater at each time point in both OCA cohorts compared with placebo, with the highest responder rates observed in the OCA 10 mg group; In the OCA titration group, 17% were responders at DB Months 9 and 12. In the OCA 10 mg group, the highest responder rate was observed at DB Month 9, followed by DB Month 12; In the open-label extension intent-to-treat population, the proportion of responders generally increased over time, ranging from 18% at OLE Month 3 to 38% at OLE Month 51. At OLE Month 60, 37% were responders.