Intercept And Obeticholic Acid In NASH: Singing The Blues
(WorldNews Health)

Market Assessment Intercept (ICPT) is a mid-cap ($2.5B) commercial-stage biopharma that focuses on the clinical development of innovative therapeutics for liver diseases. In Q1/2019, Intercept reported clinical success for obeticholic acid (OCA) in the Phase 3 REGENERATE study of patients with NASH fibrosis. A tremendous clinical achievement given the complex pathophysiology of NASH. However, the associated adverse events of pruritus, dyslipidemia (i.e. high LDL-cholesterol) and hepatobiliary events associated with OCA therapy dampened the market`s enthusiasm with a short-lived stock rally. These safety and tolerability signals may limit the broad therapeutic application of OCA in NASH. In...