The first patient has been dosed in a P-II study evaluating a fixed-dose combination of OCA + BZF in ~60 patients with PBC who have not achieved an adequate biochemical response to UDCA across the US
The study will evaluate the reduction in ALP @12wks., followed by a long-term safety extension while the 2EPs include safety, tolerability & other biochemical markers of disease progression i.e., AST, GGT, ALT, and bilirubin
The second P-II study is currently ongoing in the EU to evaluate the different dosing regimens of OCA + BZF while the P-I study is also undergone in the US in healthy adult patients. Additionally, all three studies help to identify the dose selection and study design for a P-III trial
Ref: Globe Newswire | Image: Intercept
