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 - Seite 3

“Results from these studies illustrate the OCA-bezafibrate combination’s potential to deliver biochemical responses across a range of biomarkers that predict improved clinical outcomes in PBC,” said Cynthia Levy, M.D., Hepatologist at the University of Miami Hospital and Professor of Medicine at the University of Miami. “These positive findings, including low rates of pruritus, are an important milestone for the PBC community.”

The company is continuing its two ongoing Phase 2 studies (747-213 / NCT04594694, 747-214 / NCT05239468) that are exploring a range of therapeutic doses and formulations for the combination of OCA and bezafibrate. The Company expects to have the necessary data from the OCA-bezafibrate combination program to submit a request in 2023 for an End-of-Phase 2 meeting with the FDA. These data include analyses from both Phase 2 studies, in addition to Phase 1 and preclinical data.

Poster Presentation
“Combined Effect of Obeticholic Acid and Bezafibrate in Patients with Primary Biliary Cholangitis and Inadequate Response to Or Intolerance of Ursodeoxycholic Acid: Results from Two Phase 2 Clinical Trials” Poster #5019-C
Monday, November 13, 1-2 PM ET
Cynthia Levy, Vaclav Hejda, Alexandre Louvet, Ziad Younes, Manuel Mendizabal, Alan Bonder, Heng Zou, Antonio Civitarese, Alejandra Villamil and Frederik Nevens

A full list of sessions at The Liver Meeting 2023 is available at https://www.aasld.org/the-liver-meeting.

About the Investigational OCA-Bezafibrate Fixed-Dose Combination
Intercept, a wholly owned subsidiary of Alfasigma S.p.A., is investigating a fixed-dose combination of OCA and bezafibrate for the potential treatment of individuals with PBC. OCA, a farnesoid X receptor (FXR) agonist, is marketed by Intercept as Ocaliva in the United States for the treatment of PBC (see below for full indication and Important Safety Information). Bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, is not approved in the United States for any indication.

FXR and PPAR are common and distinct pathways that each play a role in PBC. Simultaneously targeting both pathways may offer the greatest potential to impact bile acid synthesis, metabolism, and clearance that underly cholestatic liver diseases. Published studies establish a clinical proof-of-concept which suggests that the combination of OCA and bezafibrate may provide additive clinical efficacy and tolerability benefits that are unmatched in the treatment of PBC. OCA-bezafibrate combination therapy is investigational; safety and efficacy have not been established.