Second year of funding will cover efforts to obtain FDA licensure.
Elusys Therapeutics has been awarded a second contract year of funding valued at $40.6 million for the development of Anthim for the prevention and treatment of anthrax infection following a biowarfare attack.
The second year of the contract will support the company’s efforts to gain FDA licensure, including manufacturing activities, human safety trials, and nonclinical effectiveness studies in animals. Elusys has completed two safety studies in humans with Anthim and numerous studies demonstrating safety and efficacy in animal models.
The treatment is a high-affinity, humanized, and deimmunized mAb that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins. “Anthim consistently provides significant survival benefit in the treatment of anthrax infection in animal models and is well-tolerated when administered to human subjects,” says Elizabeth Posillico, Ph.D., president and CEO of Elusys.
Today’s award is in addition to $16.8 million already received under this contract and is part of a potential five-year contract that could total $143 million. Anthim has been granted fast-track status and orphan drug designation by the FDA.
Elusys also recently received funding to support further development of an intramuscular formulation of Anthim from the DoD. Such a formulation has the potential to allow rapid administration of antitoxin treatment to large numbers of people in an emergency setting, Elusys notes.