Elusys Therapeutics, Inc., published data on Thursday on more than 450 healthy adult subjects from five clinical trials used to support recent U.S. Food and Drug Administration (FDA) marketing approval of ANTHIM injection.
ANTHIM is used in adult and pediatric patients for the treatment of inhaled anthrax due to Bacillus anthracis in combination with antibacterial drugs. The treatment is used for prophylaxis of inhaled anthrax when alternative therapies are not available or appropriate.
ANTHIM is a monoclonal antibody that binds to the protective antigen component of anthrax toxin. The treatment’s anthrax-neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding any further spread of the toxin throughout the body and ensuing tissue damage. The treatment is supplied as a single-dose vial for IV-infusion.
Elusys was awarded a $45 million delivery order from the U.S. government in November to supply ANTHIM for the U.S. Strategic National Stockpile. The ANTHIM program was supported primarily by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority.
The results from the studies were published online in the journal Clinical Therapeutics.
Elusys Therapeutics develops antibody therapeutics for the treatment of various infectious diseases.