Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting 2023

Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks

OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint)

Treatment-emergent adverse events were generally balanced across all cohorts in both studies

Data support progression to Phase 3 trials of sustained release formulation of bezafibrate with low doses of OCA

Results featured in late-breaking poster presentation on Monday, November 13, during The Liver Meeting 2023

MORRISTOWN, N.J., Nov. 13, 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 two Phase 2 studies, including a topline full data analysis (Study 747-213) and an interim analysis (Study 747-214), evaluating the effects of the investigational combination of farnesoid X receptor (FXR) agonist, obeticholic acid (OCA) and peroxisome proliferator-activated receptor (PPAR) agonist, bezafibrate, on multiple key serum biomarkers in primary biliary cholangitis (PBC) that have been shown to predict 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 (poster #5019-C).

“The results of both Phase 2 studies reinforce our excitement for the combination of OCA-bezafibrate to build on the improved transplant-free survival seen in patients with PBC taking OCA across multiple real-world studies,” said M. Michelle Berrey, M.D., M.P.H., President of Research & Development and Chief Medical Officer of Intercept. “These data support progression to Phase 3 trials of the sustained release formulation of bezafibrate with low doses of OCA, an important step as we continue to prioritize Intercept’s investment in PBC.”

Patients with PBC in Study 747-213 were randomized 1:1:1:1 to receive 12 weeks of once-daily oral therapy in addition to ongoing ursodeoxycholic acid (UDCA) treatment (if any) in one of four treatment arms:

• bezafibrate 200 mg immediate release (B200 IR) (n=19)
• bezafibrate 400 mg sustained release (B400 SR) (n=19)
• bezafibrate 200 mg IR + OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B200 IR) (n=19)
• bezafibrate 400 mg SR + OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B400 SR) (n=18)

Patients with PBC in Study 747-214 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: