Elusys Therapeutics, Inc. (Elusys), a privately-held biopharmaceutical company, announced today that it has been awarded a second contract year of funding valued at $40.6 million for the advanced development of Anthim for the prevention and treatment of anthrax infection following a biowarfare attack. This funding is in addition to $16.8 million already received under this contract and is part of a potential five year contract award totaling up to $143 million if all options are exercised by the Government. 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 U.S. Department of Health and Human Services. 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. 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.
If all activities in the development program are completed to the U.S. Food and Drug Administration's (FDA) satisfaction, the federal government could purchase Anthim for the Strategic National Stockpile 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.
"We are delighted by our continued progress with Anthim's development and BARDA's ongoing commitment to further support our efforts," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Anthim consistently provides significant survival benefit in the treatment of anthrax infection in animal models and is well-tolerated when administered to human subjects. Anthim has the potential to deliver considerable therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency."
The second year of the contract, one of the largest contracts awarded by BARDA for advanced product development, will support the company's efforts to gain FDA licensure, including manufacturing activities, human safety trials, and non-clinical effectiveness studies in animals. 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.
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