Intercept Pharmaceuticals, Inc. announced results from a new analysis examining obeticholic acid?s (OCA) potential to improve transplant-free survival in patients with PBC. The data will be featured in a late-breaking podium presentation at The Liver Meeting?, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is being held virtually from November 12, 2021 to November 15, 2021. The POISE long-term safety extension (LTSE) study included 209 patients dosed with OCA with a maximum follow-up time of 6.3 years. Propensity score-matched external controls were patients from the Global PBC (n=1,391) and UK-PBC (n=2,138) real-world databases who were diagnosed with PBC and who met POISE clinical trial entry criteria. Patients from the external control databases were untreated or treated with ursodeoxycholic acid (UDCA) with at least one year of follow-up but were not treated with OCA or other therapies. The primary endpoint was time to liver transplantation or death. In this analysis, 209 patients treated with OCA in the POISE LTSE study had significantly great transplant-free survival than patients in the external control groups. In the OCA arm, three events were observed versus 146 and 276 events in the Global PBC and UK-PBC external control cohorts, respectively. In a weighted analysis, the hazard ratio favoring OCA was 0.20 (0.06-0.64, p=0.001) in Global PBC and 0.28 (0.09-0.90, p=0.033) in UK-PBC. Thus, patients treated with OCA had a 72% to 80% low risk of death or liver transplant than the control groups at any time during follow-up. Consistent findings were observed in multiple sensitivity analyses, as well as when testing for the influence of recruitment bias and potential confounding factors such as baseline bilirubin, ALP, AST or ALT, age, PBC duration, UDCA use, diagnosis year and sex.