Intercept Announces New Findings from Long-term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD The Liver Meeting 2023

New analysis demonstrates the impact of OCA on achievement of GGT <3.2×ULN and ALP <1.5×ULN

Findings suggest that OCA has the potential to reduce the liver biomarker GGT, in addition to well-known effects on ALP, below thresholds that predict improved outcomes, including survival, in PBC

Data to be featured in poster presentation on Monday, November 13

MORRISTOWN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly-owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced new data from a sub-analysis of the landmark Phase 3 POISE trial evaluating the impact of obeticholic acid (OCA) on achievement of gamma-glutamyl transferase (GGT) <3.2×upper limit of normal (ULN) and alkaline phosphatase (ALP) <1.5×ULN for the treatment of primary biliary cholangitis (PBC). 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’ (AASLD) The Liver Meeting in Boston.

“These new data demonstrate the potential of OCA to reduce GGT, in addition to the already established effect on ALP levels, which have been shown to be predictive of risk of liver transplantation or death in patients with PBC,” said M. Michelle Berrey, M.D., M.P.H., President of Research & Development and Chief Medical Officer of Intercept. “With the increasing evidence of improved event-free survival for patients treated with OCALIVA across different studies, it was important to improve our understanding of OCALIVA’s impact on different biochemical markers and how that correlates with improved outcomes. We are pleased to join clinicians, researchers and industry peers at The Liver Meeting 2023 to share these data that reaffirm the need for comprehensive assessment of treatment response beyond ALP when managing patients with PBC.”

In the study, patients with PBC who were receiving a stable dose of ursodeoxycholic acid (UDCA) or who were unable to tolerate UDCA were randomized to receive placebo, OCA 5-10 mg (OCA titration), or OCA 10 mg daily. For the OCA 5-10 mg group, OCA 5 mg was titrated to 10 mg at 6 months based on tolerability and biochemical response. A 12-month double-blind (DB) period was followed by a 5-year optional open-label extension (OLE), in which all patients were initially treated with OCA 5 mg daily for the first 3 months; every 3 months thereafter, patients had the option to increase the dose up to 10 mg. Serum GGT and ALP levels were assessed at baseline and every 3 months through the 5-year follow-up.