AstraZeneca has reported that it has initiated patient dosing in a global Phase IIb study of AZD9773 (CytoFab), a first in class anti-TNF-alpha polyclonal antibody fragment product for the treatment of severe sepsis.
The multi-centre, randomised, double-blind, placebo controlled Phase IIb study is designed to compare the safety and efficacy of AZD9773 with a placebo in adult patients who have severe sepsis or septic shock and are receiving best supportive care.
The study will enrol 300 patients and will evaluate the efficacy of two intravenous dosing regimens of AZD9773.
The study’s primary outcome measure will be the number of ventilator-free days during the 28 days after the first dose, and secondary outcome measures will be seven and 28-day patient mortality, and characterisation of the safety and tolerability of AZD9773.
AstraZeneca has also initiated a dose escalation Phase II study of AZD9773 in Japan, which will evaluate the safety, tolerability and pharmacokinetics of intravenous infusions of the drug in patients with severe sepsis or septic shock.