Intercept Announces New Data to be Presented at The European Association for the Study of the Liver (EASL) Congress 2023 and Provides Update on OCA-bezafibrate Fixed-Dose Combination (FDC) Development Program Accepted abstracts include podium presentation of new data from the planned interim analysis of a Phase 2 study of investigational combination of obeticholic acid (OCA) and bezafibrate in PBC MORRISTOWN, N.J., April 27, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that seven abstracts in PBC and NASH have been accepted for presentation at EASL 2023. The congress will be held from June 21-24, 2023, in Vienna, Austria. “We look forward to the opportunity to share new data in PBC and NASH at EASL 2023, including a podium presentation of new Phase 2 interim data from our clinical development program investigating the combination of obeticholic acid and bezafibrate,” said M. Michelle Berrey, MD, MPH, President of Research & Development and Chief Medical Officer of Intercept. “We believe that a fixed-dose combination of OCA and bezafibrate presents an opportunity to optimize the doses of each medicine and further improve the treatment of PBC, with the potential to establish best-in-class clinical benefits. This next-generation investigational therapy is an important component of our long-term strategy and ongoing commitment to people living with PBC.” Intercept has completed a Phase 1 clinical study in healthy adult subjects that assessed multiple dose combinations of OCA and bezafibrate. The company also 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, with the first data being presented at EASL 2023. The planned interim 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 the FDA. Available information about the Intercept abstracts accepted for presentation at EASL 2023 is listed below. More information about these abstracts will be made available after the respective embargoes, as set by the EASL organizers, are lifted for each presentation. A full list of sessions at EASL 2023 is available at www.easlcongress.eu.
Friday June 23, 8:30 – 9:45 CEST
Vaclav Hejda, Alexandre Louvet, Antonio Civitarese, Lynda Szczech, Heng Zou and Frederik Nevens
Wednesday June 21, 9:00 – 18:00 CEST
Alan Bonder, Nicholas Procaccini, Mary Erickson, Erik Ness, Antonio Civitarese and Kris V. Kowdley
“Risk Of Death, Liver Transplant, or Hepatic Decompensation in Primary Biliary Cholangitis Increases with Increased Duration and Degree Beyond Established Clinical Thresholds for Hepatic Biomarkers and Fibrosis Scores” Abstract #1522 Wednesday June 21, 9:00 – 18:00 CEST
Kris V. Kowdley, Tracy Mayne, Erik Ness, Darren Wheeler, Radhika Nair, Nicholas Procaccini, Leona Bessonova, Joanna P. MacEwan, Alina Levine and Gideon Hirschfield
“Fibrosis-4 Score Less Than 2.67 and Normal Gamma-Glutamyl Transferase Levels are Associated with High Negative Predictive Value for High-Risk of Liver Stiffness in Patients with Primary Biliary Cholangitis” Abstract #1518 Friday June 23, 9:00 – 18:00 CEST
Alan Bonder, Vilas R. Patwardhan, Joanna P. MacEwan, Anran Shao, Leona Bessonova, Erik Ness, Tracy Mayne, Darren Wheeler, Radhika Nair, Jing Li and Shari Orbach
Friday June 23, 9:00 – 18:00 CEST
Zobair M. Younossi, Lee Feinman, Amarita S. Randhawa, Rina Leyva, Maria Stepanova and Sangeeta Sawhney
Friday June 23, 9:00 – 18:00 CEST
Manal F. Abdelmalek, Thomas Capozza, Pamela J. Davis, Amarita S. Randhawa and Sangeeta Sawhney
Saturday June 24, 9:00 – 18:00 CEST
Rohit Loomba, Quentin M. Anstee, Stephen A. Harrison, Naim Alkhouri, Mary E. Rinella, Thomas Capozza, Chris Gasink and Amarita S. Randhawa
The use of OCA for fibrosis due to NASH is investigational and has not been approved by FDA or any other health authority. FXR and PPAR are 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 that suggests that the combination of OCA and bezafibrate may provide additive clinical efficacy and tolerability benefits in the treatment of PBC. OCA-bezafibrate combination therapy is investigational; safety and efficacy have not been established. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION
Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension, or experience clinically significant hepatic adverse reactions while on treatment. OCALIVA is contraindicated in patients with: complete biliary obstruction
Hepatic Decompensation and Failure in PBC Patients with Cirrhosis Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible. The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin. CYP1A2 Substrates with Narrow Therapeutic Index Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin. Please click here for Full Prescribing Information, including Boxed WARNING.
Forward Looking Statements
This press release contains forward-looking statements (“FLS”), including regarding:
the progress, timing and results of our clinical trials;
the timing and acceptance of our regulatory filings.
Important factors could cause actual results to differ materially from the FLS. For example:
any future determination that the regulatory applications and subsequent information we submit for our product candidates, including OCA for liver fibrosis due to NASH and the OCA-bezafibrate FDC for PBC, do not contain adequate clinical or other data or meet applicable regulatory requirements for approval; any potential side effects associated with Ocaliva for PBC, OCA for liver fibrosis due to NASH or our other product candidates that could delay or prevent approval, require that an approved product be taken off the market, require the inclusion of safety warnings or precautions, or otherwise limit the sale of such product or product candidate; the initiation, timing, cost, conduct, progress and results of our research and development activities, preclinical studies and clinical trials, including any issues, delays or failures in identifying patients, enrolling patients, treating patients, retaining patients, meeting specific endpoints, or completing and timely reporting the results of our NASH or PBC clinical trials; the outcomes of interactions with regulators including the FDA regarding our clinical trials;
our ability to identify, develop and successfully commercialize our products and product candidates; and
our ability to obtain and maintain intellectual property protection for our products and product candidates, including our ability to cost-effectively file, prosecute, defend and enforce any patent claims or other intellectual property rights.
For more information about Intercept, please contact:
Nareg Sagherian, Executive Director, Global Investor Relations
investors@interceptpharma.com
Karen Preble, Executive Director, Global Corporate Communications
media@interceptpharma.com