icg-001 and End-Stage-Liver-Disease

We conducted an exploratory study to assess the safety tolerability, and anti-fibrotic effects of PRI-724, a CBP/β-catenin inhibitor, in patients with hepatitis C virus (HCV)- and hepatitis B virus (HBV)-induced cirrhosis.. Three patients from phase 1 who received the recommended PRI-724 dose were evaluated to obtain efficacy and safety data in phase 2a. Serious adverse events occurred in three patients, one of which was possibly related to PRI-724. The most common adverse events were diarrhoea and nausea. PRI-724 did not decrease hepatic fibrosis with any statistical significance, either by ordinal scoring or measurement of collagen proportionate area at 12 weeks; however, we observed statistically significant improvements in liver stiffness, Model for End-stage Liver Disease score, and serum albumin level.. AMED, Ohara Pharmaceutical.

Topics: Antiviral Agents; beta Catenin; Bridged Bicyclo Compounds, Heterocyclic; End Stage Liver Disease; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; Herpesvirus 1, Cercopithecine; Humans; Liver Cirrhosis; Pyrimidinones; Severity of Illness Index; Treatment Outcome