New York-based Intercept Pharmaceuticals has released data from three studies related to the Phase 3 POISE trial of Ocaliva. The POISE trial tested daily Ocaliva treatment in patients with primary biliary cholangitis with an inadequate therapeutic response to ursodeoxycholic acid.
Here's what you need to know:
1. One study used transient elastography and the AST to Platelet Ratio to evaluate the effects of Ocaliva on liver fibrosis. The study found Ocaliva-treated patients experienced improvements such as reduction in mean liver stiffness.
2. Another study focused on a subset of cirrhosis patients at the greatest risk of progression to liver-related adverse outcomes or death. The study found Ocaliva-treated patients experienced improvements in both cholestasis (alkaline phosphatase) and hepatic impairment (bilirubin).
3. A final study investigated the effects of Ocaliva in primary biliary cholangitis patients with mild and moderate renal impairment. The study found Ocaliva had no apparent effect on renal safety and patients experienced comparable results regardless of renal status.