Intercept to continue its strong investment to support Ocaliva

Intercept will continue its strong investment to support Ocaliva, the only U.S. FDA-approved second-line treatment for people living with primary biliary cholangitis. The company has generated meaningful new data with innovative studies that leverage real-world evidence and will continue to do so going forward. Intercept remains on track for a planned regulatory submission to the FDA in 2023 in support of fulfilling post-marketing requirements for Ocaliva in PBC. This submission will include data from the post-marketing study COBALT and supplementary real-world evidence from large datasets in the U.S. and Europe. Intercept will prioritize R&D investment on its fixed-dose combination of OCA and bezafibrate, a peroxisome proliferator-activated receptor agonist. The first Phase 2 interim analysis for the OCA-bezafibrate combination was presented today at the 2023 European Association for the Study of the Liver Congress. The company believes that OCA-bezafibrate offers the potential to establish best-in-class clinical benefits that can help further improve the treatment of PBC. Two ongoing Phase 2 studies are exploring a range of therapeutic doses for the combination, with planned interim analyses from both studies expected to be completed in 2023. The planned interim analyses from Phase 2 studies, in addition to Phase 1 and preclinical data, will serve as the basis for an end-of-phase 2 meeting with FDA. The company continues to advance the Phase 2a FRESH study for INT-787, a next-generation farnesoid X receptor agonist, to establish a proof-of-concept in severe alcohol-associated hepatitis.