--> ICPT +2.70%
Intercept Pharma announces positive results from phase 2 AESOP trial evaluating OCA for the treatment of patients with primary sclerosing cholangitis at The Liver Meeting 2017; OCA met the primary endpoint of alkaline phosphatase reduction at 24 weeks (65.60 -1.25)
- OCA achieved the primary endpoint of the AESOP trial: patients receiving 5 mg of OCA daily with the option to titrate to 10 mg achieved a statistically significant reduction in alkaline phosphatase (ALP) as compared to placebo at week 24 (p<0.05). The results from this dose-ranging study suggest that 5 mg may be the optimal titrated dose of OCA in this patient population. Patients in the OCA 1.5-3 mg group also achieved statistically significant reductions in ALP versus placebo as measured by LS mean percent change from baseline at week 24. By week 24, ALP increased 1% in the placebo group and decreased by 22% in both the OCA 1.5-3 mg and OCA 5-10 mg groups (p<0.05).
- There are currently no approved medications for PSC. Some patients are treated with ursodeoxycholic acid (UDCA) even though the AASLD treatment guidelines for PSC recommend against its use. In AESOP, a significant proportion of patients used UDCA, with 48%, 48% and 46% of patients on placebo, OCA 1.5-3 mg and OCA 5-10 mg, respectively, receiving UDCA at baseline.