Elusys Therapeutics, Inc., announced it has been awarded $16 million of additional funding from the U.S. Government to further advance development of a lyophilized form of Anthim® (obiltoxaximab), an investigational agent for the treatment of inhalational anthrax infection following a biowarfare attack.
The company has now received total authorized funding of $195 million under two advanced development contracts for Anthim from 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.
Lyophilization (freeze drying) of the current liquid formulation of Anthim has the potential to extend product shelf-life once in the Strategic National Stockpile (SNS), the U.S. Government’s repository of critical medical supplies for biowarfare and public health emergency preparedness. Lyophilization also has the potential toimprove tolerance of Anthim to extreme temperatures during shipping and field use. These improvements could enhance operational flexibility and improve life cycle management.
The funds will be used to continue Elusys’ lyophilization development program and validation of the commercial production process. In addition to BARDA, Elusys has received prior funding from the U.S. Department of Defense and the National Institutes of Health to support the development of its liquid form of Anthim.
“We are pleased to have the ongoing support of the U.S. Government, to further improve the potential usefulness of Anthim to protect the American public, military personnel and first responders in an emergency,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “A lyophilized form of Anthim has the potential for longer shelf life and improved temperature stability in the field, as well as greater efficiencies in managing anthrax antitoxins in the SNS.”
The FDA is currently reviewing Elusys’ Biologics License Application (BLA) for the liquid form of Anthim for treatment of inhalational anthrax in combination with appropriate antibiotics and prophylaxis when alternative therapies are not available or are not appropriate. Anthim is a candidate for future acquisition into the SNS. Anthim was granted Fast-Track status and Orphan Drug Designation by the FDA.
Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics. In the 2001 anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 50% in humans infected, even when victims were given antibiotics and supportive hospital care. Under current guidelines, CDC recommends the use of anthrax antitoxins with antibiotics in cases where there is a high level of clinical suspicion for systemic anthrax.
