Intercept announces Phase 2 AESOP trial met primary endpoint
Intercept Pharmaceuticals announced that the Phase 2 AESOP trial evaluating obeticholic acid, or OCA, for the treatment of patients with primary sclerosing cholangitis, PSC, met its primary endpoint. Patients who initiated OCA 5 mg with the option to titrate to 10 mg achieved a statistically significant reduction in alkaline phosphatase, or ALP, as compared to placebo. AESOP is a 24-week, double-blind, placebo-controlled, dose-ranging trial evaluating the efficacy and safety of OCA compared to placebo in 77 patients with PSC, followed by a two-year long term safety extension, or LTSE, open-label phase which is currently ongoing. Patients were randomized to one of three treatment groups: placebo, OCA 1.5 - 3 mg, and OCA 5 - 10 mg. Approximately half the patients were receiving ursodeoxycholic acid, or UDCA, treatment at baseline and continued on a stable dose during the trial. The primary endpoint of the study was the change in ALP relative to placebo at week 24 for the OCA 5 - 10 mg group. Results for the intent-to-treat population are shown below.