New Data from the Interim Analysis of REGENERATE Show OCA Improved Noninvasive Measures of Fibrosis in a Subgroup of High-Risk Patients with Fibrosis Due to NASH
Multiple new analyses reinforce the clinical value of noninvasive strategies to identify and monitor patients with advanced fibrosis due to NASH
NEW YORK, Nov. 16, 2020 (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 multiple new analyses supporting the use of routine noninvasive tests (NITs) to identify patients with advanced fibrosis due to NASH and
measure obeticholic acid (OCA) treatment response. The new analyses, which include an oral presentation of REGENERATE interim analysis data showing that OCA helped patients achieve marked
improvements in key noninvasive measures of liver fibrosis, are being presented at The Liver Meeting Digital Experience, the Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD), which will be held virtually from November 13, 2020 to November 16, 2020.
“NITs are rapidly replacing liver biopsy for identifying and monitoring patients with advanced fibrosis due to NASH in routine clinical practice, and this year’s Liver Meeting features a wealth of new data reinforcing the value of noninvasive strategies to manage patients treated with OCA,” said Naim Alkhouri, M.D., Chief of Transplant Hepatology, and Director of the Fatty Liver Program at Arizona Liver Health in Phoenix. “Using a simple, sequential algorithm with two common NITs, we were able to identify a higher-risk subgroup of patients with fibrosis due to NASH and evaluate their treatment response noninvasively; these patients achieved marked reductions in measures of liver biochemistry and liver stiffness as assessed by transient elastography through 18 months of treatment.”
As previously reported, once-daily OCA 25 mg met the primary composite endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis of the Phase 3 REGENERATE study with high statistical significance (p=0.0002 vs. placebo). The new post hoc analysis being presented at The Liver Meeting evaluated the NIT-based efficacy of OCA in patients from the intent-to-treat population of the REGENERATE interim analysis who had Fibrosis-4 (FIB-4) and transient elastography data available at baseline. FIB-4 and transient elastography were applied sequentially to categorize patients’ fibrosis severity; patients with possible advanced fibrosis (indeterminant status) or advanced fibrosis were pooled (OCA 25 mg, n=266; placebo, n=277). At month 18, OCA reduced mean alanine aminotransferase (ALT) scores and median transient elastography scores by 50.1% and 25.6%, respectively; reductions for placebo were 30.2% and 4.2%, respectively, suggesting that such noninvasive assessments can be utilized to monitor fibrosis improvement in OCA-treated patients.