ELUSYS & BIODEFENSE
ELUSYS AND BIODEFENSE
Anthrax or Bacillus anthracis has long been regarded as the number one bio-terror threat by the Department of Homeland Security (DHS) due to its ability to be easily weaponized and distributed over large metropolitan areas by planes and ventilation systems. Following the 2001 anthrax attacks, the US government recognized the need to develop more effective therapeutic countermeasures to protect Americans from a large-scale attack. Antibiotics were used to treat infected individuals but 50% of patients with advanced symptoms still did not survive. In 2003, the US Government established a $5.6B reserve fund for the stockpiling of counter-measures against threats of bioterrorism. Importantly, anthrax has been designated a significant material threat by the DHS prompting the need to stockpile more effective countermeasures.
ETI-204 is a monoclonal antibody currently under development for the treatment and prophylaxis of inhalational anthrax infection. ETI-204 neutralizes the Protective Antigen protein produced by anthrax bacteria during an infection, which prevents the protein from binding to cells and, thereby, inhibits the formation of toxins. The toxins produced by anthrax are responsible for the bacteria’s high mortality.1
ETI-204 has the potential to both treat and protect against inhalational anthrax infection. Antibiotics and vaccines work by different mechanisms of action and affect different targets. ETI-204 is in the final stage of development and a commercial manufacturing process has been established.
ETI-204 has been shown to be active in animal models of inhalational anthrax both as treatment for symptomatic animals and as prophylaxis. ETI-204 has been evaluated in three completed human studies assessing the pharmacokinetics and safety of IV administration. The more common adverse events related to ETI-204 administration across the three studies included upper respiratory tract infection, nausea, headache, nasal congestion and erythema. ETI-204 has been formulated as a concentrated liquid formulation to enable administration via IV infusion and potentially via IM injection.
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1. Walsh James J. , Pesik Nicki, et al. A Case of Naturally Acquired Inhalation Anthrax: Clinical Care and Analyses of Anti–Protective Antigen Immunoglobulin G and Lethal Factor. Clinical Infectious Diseases 2007; 44:968–71