New Data Shows Intercept's Fixed Dose Obeticholic Acid Combo Normalize Multiple Biomarkers In Liver Disease

Intercept Pharmaceuticals Inc 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). 

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.