FOR THE TREATMENT AND PROPHYLAXIS OF INHALATIONAL ANTHRAX
In March 2016, Elusys Therapeutics, Inc. (Elusys) announced that the U.S. Food and Drug Administration (FDA) has approved ANTHIM (obiltoxaximab) Injection, the company’s monoclonal antibody (mAb) anthrax antitoxin. ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding
further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for intravenous (IV) infusion. ANTHIM should be used in combination with appropriate antibacterial drugs and only for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. Due to ethical concerns, there have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax.
“This marks a historic milestone for our company, resulting from an unprecedented partnership with several government agencies, to develop a new anthrax antitoxin that will be an important addition to the Strategic National Stockpile (SNS) and help protect the safety of our citizens and emergency personnel in the event of biowarfare attack. We are continuing product development to deliver additional treatment options to the SNS and further protect Americans” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys.
Anthrax is a disease caused by Bacillus anthracis. While it is primarily a disease of animals, cases of anthrax in humans occur through contact with infected animals or animal products or through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent.
Anthrax is regarded as a top (“Category A”) biological warfare and bioterrorism threat for a number of reasons:
- The fatality rate of inhalational anthrax may be as high as 90% if untreated.
- anthracis is widely available. The spores are hardy and tolerant to temperature, humidity, and light.
- Techniques for mass production and aerosol dissemination of anthrax have been developed.
- anthracis has been used in the past as a biological weapon.
Symptoms of inhalational anthrax develops in two phases; in the first 3-4 days, patients experience flu-like symptoms. A transition to systemic illness follows abruptly, with high fever, shortness of breath, excessive sweating, and shock.
About Elusys Therapeutics, Inc.
Elusys Therapeutics, Inc., a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. Elusys has received over $240 million in development grants and contracts from the U.S. Department of Defense (DoD), National Institutes of Health (NIH) and BARDA. In November 2015, Elusys was awarded a $45M delivery order from the U.S. government to produce ANTHIM for the U.S. Strategic National Stockpile (SNS), the U.S. government’s repository of critical medical supplies for public health emergency preparedness. Current investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures, MedImmune Ventures and Pfizer.