Product: Myrcludex B, a peptide inhibiting the penetration of virus into the liver cells.
Therapeutic focus: Chronic viral hepatitis B (HBV); chronic hepatitis D (HDV). In the future, indications for use can be expanded: viral encephalitis and other forms of hepatitis, HIV.
Status: Phase 2 clinical trials.
Partner: MYR, GmbH (Germany)
Myrcludex B is a novel drug candidate, being a linear 47-amino acid chemically synthesized peptide. So far it is the single representative of a novel class of anti-HBV molecules, called entry inhibitors. The postulated mechanism of antiviral action is the highly specific and highly stable binding to HBV receptors on the surface of hepatocytes, which misdirects HBV to an unproductive pathway and thereby prevents an infection of the cell. This unique mechanism of action offers the possibility to address the two most important medical needs, namely long-term HBV eradication as well as antiviral activity against hepatitis D virus (HDV).
Despite the availability of appropriate drugs, there is still a number of unresolved medical problems concerning the treatment of hepatitis B, namely, how to achieve long-term eradication of the virus and how to prevent drug resistance. In view of the above it is essential to develop new therapies aimed at the still untouched stages of viral replication, such as the stage of the virus into hepatocytes.
In addition a similar mechanism of action provides the opportunity to prevent the development of delta hepatitis (hepatitis D).
By the end of 2011 Myrcludex B’s safety was shown in a series of preclinical studies — antiviral activity was assessed in in vitro and in vivo experiments. In anin vivo model with transplanted hepatocytes susceptible to hepatitis B virus, adding Myrcludex B completely prevented development of HBV infection. In early 2012 results from the clinical trial phase Ia showed the safety and good tolerability of Myrcludex B in humans. In 2015 the company completed Phase Ib/IIa clinical trial for patients suffering from chronic hepatitis B. In 2016 Hepatera is completing the pilot study of Myrcludex B in chronic hepatitis D patents.
Currently Hepatera is conducting two phase II clinical trials in chronically HBV/HDV сo-infected patients. Clinical trials will assess the efficacy and safety of Myrcludex B in different dosages and therapy regimens.
In 2012 Hepatera finished Phase Ia clinical trial of Myrcludex B in patients with chronic viral hepatitis B. The results have showed the safety and good tolerability of drug. The company also finished Phase 2a clinical trial in chronic HBV infection and substudy in chronic HDV infection. The studies were conducted in Russian Federation. Myrcludex B has shown good safety profile and antiviral activity in the clinical trials.
Currently Hepatera is conducting two phase 2 clinical trials in chronically HBV/HDV сo-infected patients. Clinical trials will assess the efficacy and safety of Myrcludex B in different dosages and therapy regimens.