ALF-5755: Phase II data
A double-blind, European Phase II trial in 57 patients with HBV- and autoimmune-related acute-on-chronic liver disease or acute liver disease showed that 10 mg IV ALF-5755 every 12 hours for 3 days missed the primary endpoint in the overall population of improving prothrombin time at day 3 vs. placebo. ALF-5755 also missed the secondary endpoints of improving liver transplantation rate and hospitalization time vs. placebo. In the subgroup of patients with HBV- and autoimmune-related acute-on-chronic liver disease (n=22), ALF-5755 significantly improved prothrombin time compared to placebo at 12 hours (p=0.03), at day 3 (p=0.04) and at day 8 (p=0.007). No significant safety issues were reported. Prothrombin is a protein made by the liver and a high prothrombin time - how long it takes blood to form a clot - is indicative of serious liver damage or cirrhosis. Data were presented at the American Association for the Study of Liver Diseases meeting in Washington, D.C. ...