Elusys continues to work closely with the U.S. Food and Drug Administration (FDA) on the design of the ETI-204 Phase 3 development program in preparation for an anticipated End of Phase 2 meeting. ETI-204 was granted Fast Track status and Orphan Drug Designation in 2006 by the FDA.
ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen. It is an investigational agent being developed for treatment of inhalational anthrax following a biowarfare attack.
ETI-204 efficacy and safety are being studied in animals and safety studies are being conducted with human volunteers. To date, five studies assessing the efficacy and safety of ETI-204 in animals with inhalational anthrax have been completed, and three studies assessing pharmacokinetics and safety of IV administration of ETI-204 in humans have been conducted. In the two completed studies, the adverse event profile of ETI-204 was comparable to placebo and the more common adverse events related to ETI-204 administration were headache and upper respiratory tract infection. ETI-204 is formulated as a solution suitable for either IV or IM administration. This program is supported with federal funds from the Office of the Assistant
SOURCE Elusys Therapeutics, Inc.
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