Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing biodefense countermeasures, announced that it has been awarded the first US Government contract to develop an anti-toxin for pre- and post-exposure prophylaxis (PEP) use via intramuscular injection (IM). The five year contract, totalling up to $68.9 million, will support multiple animal efficacy studies as well as human safety studies to further demonstrate the utility of Anthim (ETI-204), the company’s anti-toxin, to prevent disease and death from exposure to anthrax when administered intramuscularly before symptoms of disease are present.
Anthim is an anti-toxin that significantly increases survival in anthrax-infected animals and is a promising candidate for the treatment of anthrax infection in people following a biowarfare attack. Intramuscular injection allows for the rapid administration of a single-dose of anti-toxin to large numbers of people outside of a hospital or medical setting and will not require trained medical personnel, intravenous bags, sterile mixing and other preparations needed for intravenous administration.
“Many more people can quickly receive prophylactic treatment against anthrax infection using intramuscular administration, particularly in an emergency setting before symptoms are present,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “In several animal studies conducted to date, ETI-204 has demonstrated excellent efficacy and increased survival significantly when given in a single intramuscular dose. We are pleased to continue the advanced development of Anthim for prophylactic therapy against anthrax toxemia.”
Anthrax is a life-threatening infectious disease caused by the bacteria Bacillus anthracis and remains one of the nation’s top biowarfare threats. Inhaled anthrax is often fatal, even if treated with antibiotics, if not treated soon after exposure. If all activities in the ETI-204 development programme are completed to the US Food and Drug Administration’s (FDA) satisfaction, the federal government could purchase Anthim for the Strategic National Stockpile (SNS) under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack.
This funding is in addition to a separate contract, totalling up to $143 million over five years, previously awarded for development of Anthim for treatment of symptomatic patients. Funding will be provided by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.
Leslie Casey, PhD, vice president of Research commented that, “In a recent animal study, a single IM dose of Anthim provided a 92% survival rate when administered 18 hours after exposure to anthrax. All surviving animals tested negative for anthrax bacteria by study day 14. The results of this study, in addition to other animal studies previously conducted by the company, continue to demonstrate the significant survival benefit of ETI-204 when given to anthrax exposed animals.” This research was funded by the U.S. Department of Defense, Joint Program Executive Office for Chemical and Biological Defense - Chemical Biological Medical Systems/DoD, contract number W9113M-10-C-0024.
Elusys has completed two safety studies in humans with Anthim and numerous studies demonstrating safety and efficacy in animal models. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA.
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 inhalational anthrax following a biowarfare attack.
Anthim has been extensively tested for efficacy and safety in animals and safety in human volunteers. It shows excellent potential as an effective, life-saving therapeutic for the treatment of people infected by or exposed to anthrax spores. A single dose of Anthim consistently protects 70% to 100% of anthrax-infected animals from death.
This project is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000026C, the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), and the Department of Health and Human Services (HHS), under Contract No. HHSN272200700035C.
Elusys Therapeutics, a private company, focused on the development of antibody therapeutics for the treatment of life-threatening disease.