TetraLogic Pharmaceuticals Corporation announced that research describing birinapant's preclinical activity in a mouse model of chronic human hepatitis B virus (HBV) has been published in the journal Proceedings of the National Academy of Sciences. The publication reports preclinical studies performed at the Walter and Eliza Hall Institute of Medical Research (WEHI), Melbourne, Australia in collaboration with TetraLogic Pharmaceuticals. In studies performed by Dr. Marc Pellegrini and his colleagues in mouse models of human hepatitis B, administration of birinapant resulted in loss of HBV-DNA, loss of HBsAg and the appearance of anti-HBsAg antibodies.

A second paper describes similar results in mice where the targets of birinapant, cIAP1 and cIAP2, were ablated in the liver ("knock-out mice"). That result provides independent genetic confirmation of birinapant's mechanism of action. These experiments provided the scientific rationale for TetraLogic's ongoing multiple ascending dose study of birinapant in subjects with chronic HBV.

The trial is being conducted in subjects over the age of 18 with chronic HBV who are receiving treatment with either tenofovir or entecavir and who are HBsAg positive. The trial is expected to enroll approximately 6 cohorts of 8 subjects each, who will receive 4 weekly treatments with either birinapant or placebo in a 3:1 ratio. The study is being conducted at multiple clinical sites in Australia.

Although predominantly a safety and tolerability study, patients will also be monitored for reductions in HBsAg and formation of antibodies to HBsAg as indications of therapeutic activity.