Chronic Hepatitis B is a potentially life-threatening liver infection caused by the HBV. Worldwide, an estimated two billion people were HBV infected, whereas more than 350 million of those have chronic liver infections.
Chronic hepatitis B is a serious global public health issue. Up to 1.2 million deaths per year are caused by HBV-related chronic liver diseases resulting in it being the 10th leading cause of death worldwide. Without appropriate treatment, 15-25% of the chronically infected will die prematurely because of the severe and fatal complications of chronic liver disease.
Myrcludex B is a novel drug candidate potentially useful for treatment of chronic hepatitis B (CHB) and chronic hepatitis delta (CHD). Myrcludex B was developed by a group of scientists having access to unique tools to investigate entry events of hepatitis B virus (HBV). It is the single representative of a novel class of anti-HBV molecules, entry inhibitors.
Phase 1 clinical trial has been completed in healthy volunteers, showing excellent safety and tolerability profile. Dose regimens for use in HBV and HDV infected patients were defined based on the PK profile.
A Phase 2a clinical trial was recently completed in chronically HBV infected patients. In total, 48 patients were included at 10 sites in Russia and treated with Myrcudex B for up to 24 weeks. The drug has demonstrated excellent safety and tolerability, as well as antiviral activity.