Emricasan: Phase II data
Top-line data from a double-blind, placebo-controlled, U.S. and U.K. Phase II trial in 21 patients with ACLF showed that twice-daily 25 and 50 mg oral emricasan for 28 days reduced cleaved cytokeratin 18 ( CK18; KRT18), caspase-3 ( CASP3; CPP32)/ caspase-7 ( CASP7; MCH3) and full-length CK18 levels by >=30% from baseline at day 2. Median reductions in cleaved CK18 levels from baseline at day 2 were 13%, 44% and 54% in the 5, 25 and 50 mg emricasan cohorts, respectively, vs. 7% for placebo. The median reduction in cleaved CK18 levels was maintained through day 7 in the high-dose emricasan cohort, but not in the other cohorts. Both 25 and 50 mg also reduced IL-18 levels by about 20% from baseline at day 7. Conatus said the data suggest that higher doses of emricasan may need to be explored in the ACLF patient population. ...