Preclinical pharmacodynamics and safety profiling of AZD9773: a novel anti-TNFα polyclonal immune ovine Fab similar to D-CytoFab

The critical pathophysiological trigger of sepsis is thought to be a disturbance in the equilibrium between the proinflammatory response and concomitant anti-inflammatory mechanisms. Data show that the proinflammatory cytokine TNFα is a principal mediator of sepsis [1,2]. AZD9773 is a sterile lyophilised powder for solution for i.v. infusion containing ovine immune fragments (Fabs) of IgG that bind to human TNFα. We explored the PD and safety profile of AZD9773 in cynomolgus monkeys. AZD9773 PD data are compared with D-CytoFab (a similar ovine anti-TNFα IgG immune Fab product) that showed clinical benefit in a phase IIb study [3].