Intercept Pharmaceuticals, Inc. announced initial results from a planned interim analysis of its ongoing Phase 2 study 747-213, an active comparator trial demonstrating the therapeutic potential of the combination of obeticholic acid (OCA) and bezafibrate vs. bezafibrate monotherapy on serum biomarkers in primary biliary cholangitis (PBC). These data are part of a larger analysis that will be presented at 08:45 CEST on June 23 at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria.

Data will be presented from the planned interim analysis of patients with PBC who were randomized 1:1:1:1 to receive 12 weeks of once-daily oral therapy in addition to ongoing UDCA treatment (if any) in one of four treatment arms: bezafibrate 200 mg (B200), bezafibrate 400 mg (B400), bezafibrate 200 mg + OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B200), bezafibrate 400 mg + OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B400). Endpoints included serum biomarkers of PBC-induced liver damage such as alanine transaminase (ALT) and aspartate aminotransferase (AST) as well as markers shown to predict transplant-free survival such as alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and total bilirubin. Safety was assessed by monitoring of adverse events (AEs) and laboratory values.

As reflected in the abstract published and available on the EASL website, data from the first 45 patients enrolled in Study 213 showed that over half of those receiving OCA5-10/B400 rapidly achieved normal range ALP at 4 weeks with continued improvement through week 12. In addition, patients randomized to OCA5-10/B400 exhibited the highest rates of biomarker normalization at week 12: ALP (60% normalized), total bilirubin (100% normalized), ALT (100% normalized), and GGT (70% normalized). Low rates of AEs were observed, with a majority considered mild and not related to study drug.

Rates of pruritus were 25% or less in any treatment arm. Four patients in the study experienced severe or serious treatment-emergent AEs (TEAEs), all deemed not study-drug related. Intercept has two ongoing Phase 2 studies (747-213 /NCT04594694, 747-214 /NCT05239468) that are exploring a range of therapeutic doses for the combination of OCA and bezafibrate.

Intercept expects to complete planned interim analyses from both ongoing Phase 2 studies this year. Analyses from these Phase 2 studies, in addition to Phase 1 and preclinical data, will serve as the basis of an end-of-phase 2 meeting with FDA.