The drug specifically binds and inhibits the liver bile acid transporter protein NTCP on the hepatocyte surface, which was recently discovered to be an essential receptor for HBV and HDV infection of liver cells. Myrcludex prevents the infection of healthy healthy hepatocytes and viral spreading within the liver. Myrcludex B has shown an excellent safety profile and antiviral efficacy in several clinical trials. The drug has received Orphan Designations for the treatment of HDV infection from EMA and FDA. Myrcludex B has also received eligibility to PRIME (PRIority MEdicine) scheme by the European Medicines Agency.
Recently, MYR Pharma has announced highly positive interim results in MYR 202 clinical trial, a Phase 2b study investigating Myrcudex B in chronic hepatitis delta infection. After 24 weeks of treatment, Myrcludex B demonstrated excellent safety profile with no drug-related serious adverse events or treatment discontinuations due to the study drug. Patient`s adherence to the treatment was very high. The primary endpoint, >2 log HDV RNA decline to baseline or negativation was met for all doses of Myrcludex B. Full results of the study will be presented in the general session of EASL (Paris, France) on 12th April 2018, at 13:30.
In a Phase 2a clinical study with hepatitis B patients, Myrcludex B showed significant reduction of the viral DNA. MYR Pharma is planning additional studies to further develop the drug as a component of HBV cure.
In addition to hepatitis, Myrcludex B has a potential for the treatment of a variety of inflammatory and metabolic diseases via additional pharmacological effects of NTCP inhibition. MYR Pharma and its collaborators have obtained encouraging preclinical data that support further development of Myrcludex B to treat dyslipidemia, nonalcoholic steatohepatitis (NASH), and primary biliary cholangitis (PBC). A Phase 1 clinical trial for dyslipidemia has been initiated.
MYR Pharma is based in Burgwedel (Germany). The company started operations in 2011 and is supported by venture capital investors High-Tech-Gruenderfonds and Maxwell Biotech Venture Fund. The technology was originally developed at the University of Heidelberg (Germany) and INSERM (France) and represents one the most clinically advanced novel approaches for treatment of hepatitis B and D.