TetraLogic releases update about hepatitis B clinical program
The status update shows that the company plans to launch a combination single ascending dose/multiple ascending dose clinical trial. For chronic HBV subjects, a single agent will be birinapant. These specific subjects will only take birinapant and no other antiviral medication.
The trial’s single ascending dose phase will require that subjects receive a single dose of birinapant at 2.8 mg/m2, which will be increased until a minimum of one subject demonstrates activity evidence. This activity evidence must be an increase in liver transaminases as well, or else a decrease in circulating viral DNA. When this step is achieved, the group will expand with more subjects who will receive four administrations of birinapant on a weekly basis.
Birinapant, one of TetraLogic’s two clinical-stage product candidates in a development stage, will be evaluated to determine its safety and efficacy with liquid and solid tumors as well as specific intracellular pathogens.
TetraLogic has employed a clinical research organization for the study. The company estimates that this trial will begin in India during early 2016. The timing of the study results will depend entirely on enrollment rates as well as cohort activity.