A new therapy for chronic hepatitis B virus (HBV) will enter a phase 1/2a clinical trial. This new treatment was developed by Dr. Marc Pellegrini, Dr. Greg Ebert Walter and Eliza Hall Institute, Australia, and colleagues in collaboration with TetraLogic Pharmaceuticals, a biotechnology company located in Malvern, Pennsylvania.
Hepatitis B virus (HBV) infections cause 1 million deaths annually throughout the world. A vaccine has been accessible since 1982, although over 2 billion people in world are infected with the virus, and currently in Australia it is estimated that more than 218,000 subjects are chronically infected with hepatitis B virus, the majority of which are migrants and refugees from endemic countries for hepatitis B. The majority of the people recover from hepatitis B, but between 5 to 10% of patients will develop a chronic infection, with children being the most affected. Each year, over 780,000 people die from cirrhosis and liver cancer that originated from chronic hepatitis B infection.
The new therapy uses the drug birinapant from TetraLogic Pharmaceutical, a bivalent experimental Second Mitochondrial Activator of Caspases (SMAC)‑mimetic, that will bind mainly the Inhibitor of Apoptosis proteins or IAPs, which are a class of crucial molecules that protect cells from apoptosis, i.e. death of cells, thus through this binding the drug will promote apoptosis of infected cells.
“Our preclinical models have shown that birinapant kills infected liver cells, while not harming uninfected cells,” said Dr. Pellegrini in the press release. “Used in conjunction with an existing treatment for hepatitis B, this drug has the potential, for the first time, to functionally cure chronic hepatitis B infections.”
According to Dr. Pellegrini, this new therapy if successful will transform the current treatment of chronic HBV infections, since presently the treatment is based on drugs that inhibit the development of the virus but do not remove it entirely from the body. “These patients are dependent on anti-viral drugs that need to be taken for a very long period of time to reduce the risk of virus-induced liver damage and the complications that come with it,” said Dr. Pellegrini.
Dr. Pelligrini went on to explain that their treatment is the combination an already used anti-viral agent with birinapant that will induce an efficient death of cells infected with hepatitis B and removal of the virus from the body.
“We are really excited that this treatment has entered phase 1/2a clinical trials as it is a culmination of many years work in developing new strategies to tackle chronic infections,” highlighted Dr. Pelligrini.
The phase I/2a clinical trial is based on Dr. Pellegrini’s research data — as a result, he will be the scientific and clinical advisor of the study that will be performed in different locations in Australia and New Zealand, including Melbourne, Adelaide, Perth and Auckland. The study will be supported by TetraLogic Pharmaceuticals Corporation, the Nucleus Network in Melbourne, and hospitals across Australia and New Zealand.