Elusys' Anthim Improves Survival Of Animals Treated After Active Anthrax Infection
Elusys Therapeutics announced pivotal animal efficacy results of Anthim, a high-affinity humanized and deimmunized monoclonal antibody targeting the anthrax toxin protective antigen.
Elusys' Anthim is designed as a "just in time" anthrax therapeutic that can be administered by a single, rapid intramuscular injection and has the potential to provide quick protection against the lethal effects of anthrax toxin.
In this study, primates were infected with a highly lethal dose of aerosolized anthrax spores and observed for 60 days. A single IM dose of Anthim provided significant protection (75% survival) when administered at the onset of clinical symptoms of disease (24 hr. post exposure). These results are consistent with a recent rabbit study that showed significant survival of animals treated 24 hours after infection when bacteremia was present.
Elizabeth Posillico, Ph.D., President and Chief Executive Officer of Elusys, commented on the results, "Anthim continues to demonstrate life-saving potential when given in a single, low IM dose after clinical symptoms of infection are present. In earlier animal studies, Anthim provided 100 percent protection when given prior to an anthrax exposure. These results have been consistent across studies whether Anthim was used with or without antibiotics. Our Phase I human safety study demonstrated Anthim is safe and well-tolerated as a monotherapy and as a combined therapy with the antibiotic ciprofloxacin."
Dr. Posillico continued, "Death from the effects of anthrax toxin can occur in a few days if patients are not treated quickly. We are very excited because the results of our studies show that rapid IM treatment with Anthim has the potential to provide 'instant protective immunity' against the anthrax toxin in a bioterrorism emergency. We believe Anthim represents an extremely important medical countermeasure for the treatment of anthrax and should be added to the National Stockpile."
Currently antibiotics represent the only option for the treatment of anthrax infection. Antibiotics may be effective in killing the bacteria, but can still fail to prevent death from the damaging effects of anthrax toxins. In addition, current antibiotics may not be effective at all against antibiotic resistant strains of anthrax.
Anthim 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. It is being developed for prevention and treatment of inhalation anthrax. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA and is being developed under the FDA Animal Rule, a regulatory process specifically designed for the development of medical countermeasures to bioterror threats. Elusys has been awarded $32 million from the National Institutes of Health and the Department of Defense for development of Anthim, of which $12 million was awarded in September 2007 from the National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services for advanced development of Anthim. In April of 2007, Anthim was selected to R&D Directions' list of "100 Great Investigational Drugs."