Safety and Efficacy of a Novel Treatment for Advanced Liver Fibrosis

Abstract

Background: Liver fibrosis is the presence of excess collagen due to new fibers formation. It is classified as a component of many forms of liver disease and injury rather than a disease by itself. To-date, there is no effective treatment for liver fibrosis. The only known way for patients suffering from advanced liver fibrosis is liver transplantation. Aim: The study was conducted to prove safety of Regehep (DAH04) as a novel treatment for treatment of advanced liver fibrosis in both of healthy adult volunteers. In addition, effectiveness and tolerability of Regehep (DAH04) in patients with advanced liver fibrosis. Method: Fourteen adult volunteers were enrolled for part A and B. Part A, twelve adult healthy volunteers were randomly assigned into four groups (n = 3) as section of safety. Part B, two patients were enrolled to asses tolerability and effectiveness of Regehep in case of advanced liver fibrosis. Single ascending dose was used to asses safety in part A while therapeutic dose was used to achieve primary and secondary end point in part B. Results: There were no serious side effects as well as no serious biochemical changes after administration of single ascending doses of Regehep (DAH04) up to 25 folds of therapeutic dose. While part B, two cases of advanced liver fibrosis showed improvement of biochemical profile and ultrasound images of the liver till curing of periportal fibrosis as secondary end point. Conclusion: Regehep (DAH04) appears to be safe in doses up to 25 folds of therapeutic dose as well as effective in treatment of periportal fibrosis in late stages.