The Walter and Eliza Hall Institute is studying a potential treatment to cure chronic hepatitis B virus (HBV) infections, and is currently recruiting 50 patients to enroll in the Phase I and IIa clinical trials. The study will take place at several research sites in both Australia and New Zealand, including Melbourne, Adelaide, Perth and Auckland, and aims to evaluate an HBV treatment, using Malvern, Pennsylvania-based biotechnology company, TetraLogic Pharmaceutical‘s drug, birinapant.
The therapy was developed by one of the Institute’s research teams, led by Marc Pellegrini and Greg Ebert, in collaboration with TetraLogic Pharmaceuticals. The scientists used the company’s proprietary product birinapant, which is able to target cell proteins that prevent the self-destruction of infected cells. Pellegrini believes that by targeting those proteins, also called ‘inhibitors of apoptosis proteins’ (IAPs), they will not only target the infected cells, but also kill them. “Our preclinical models have shown that birinapant kills infected liver cells, while not harming uninfected cells,” he said. “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,” he said.
This new therapy is expected to revolutionize the treatment of chronic HBV infections, since “patients who develop chronic infections can be treated with drugs that prevent the virus from replicating, reducing the amount of virus in the liver, but do not completely eliminate the virus,” which makes these patients 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,” Pellegrini explained.
“Our new therapy combines an existing anti-viral drug, which reduces the viral load, with birinapant that promotes efficient killing of hepatitis B infected cells and clearance of the virus from the system,” the scientist added. “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.”
Pellegrini is the key scientific and clinical advisor for the clinical study, funded by TetraLogic Pharmaceuticals Corporation in collaboration with Nucleus Network in Melbourne and hospitals across Australia and New Zealand. The scientists expect to be able to improve the live of thousands of people who suffer from the disease, that can cause severe complications, including cirrhosis and liver cancer, and kills more than 780,000 patients yearly.