Two Phase 1 clinical trials has been completed in healthy volunteers, showing excellent safety and tolerability profile. A Phase 2a clinical trial was recently completed in chronically HBV infected patients. In total, 48 patients were included at 10 sites and treated with Myrcudex B for up to 24 weeks.
The drug has demonstrated excellent safety and tolerability, as well as antiviral activity. A pilot study with 24 patients suffering from hepatitis delta is fully recruited. This study with 24 patients investigates Myrcludex B as monotherapy and in combination with pegylated interferon alpha. 24-week results show significant anti-HDV efficacy as monotherapy and in combination with interferon. A Phase 2b trial in hepatitis delta infection is planed to start in the end of 2015.