NEW DATA SHOWS INTERCEPT'S FIXED DOSE OBETICHOLIC ACID COMBO NORMALIZE MULTIPLE BIOMARKERS IN LIVER DISEASE
Intercept Pharmaceuticals Inc (NASDAQ: ICPT) 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).
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As reflected in the abstract, data from the first 45 patients enrolled in Study 213 showed that over half of those receiving OCA5-10/B400 rapidly achieved normal range alkaline phosphatase (ALP) at four weeks with continued improvement through week 12.
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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 the 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 exploring a range of therapeutic doses for combining OCA and bezafibrate.
Intercept expects to complete planned interim analyses from both ongoing Phase 2 studies this year.
Price Action: ICPT shares are up 6.81% at $12.08 on the last check Wednesday.
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This article New Data Shows Intercept's Fixed Dose Obeticholic Acid Combo Normalize Multiple Biomarkers In Liver Disease originally appeared on Benzinga.com.
2023-06-07T19:27:20Z dg43tfdfdgfd