AZD9773 is a first in class anti-TNF-alpha polyclonal antibody fragment (Fab) product.
The Phase IIb study is a multicentre, randomised, double-blind, placebo controlled trial in 300 patients which will evaluate the efficacy of two intravenous dosing regimens of AZD9773.
The primary outcome measure will be the number of ventilator-free days over 28 days following first dose and the secondary outcome measures include 7 and 28 day patient mortality and characterisation of the safety and tolerability of AZD9773.
AstraZeneca has also initiated a separate Phase II study of AZD9773 in Japan.
This is a dose escalation study to assess the safety, tolerability and pharmacokinetics of intravenous infusions of AZD9773 in Japanese patients with severe sepsis and/or septic shock.
Under the terms of the global development and commercialisation agreement for AZD9773, BTG is responsible for bulk drug manufacturing, including the supply of clinical trial materials, and AstraZeneca is responsible for development and commercialisation of AZD9773.
BTG CEO Louise Makin said that they are pleased that this study is under way and the treatment of severe sepsis is a major challenge, and AZD9773 could become an important new treatment option.
"This is a dose escalation study to assess the safety, tolerability and pharmacokinetics of intravenous infusions of AZD9773 in Japanese patients with severe sepsis and/or septic shock," Makin said.