Elusys Bags $143m US Government Contract

Elusys Therapeutics (Elusys) has signed a contract totaling $143m with the US Government to complete the final development, commercial manufacturing and licensure of Anthim, a late stage anthrax therapeutic. Anthim is being developed by Elusys to treat people stricken by inhaled anthrax and to prevent illness from anthrax.

The company said that the new contract, awarded by Biomedical Advanced Research and Development Authority (BARDA) for advanced product development, will support the company’s clinical and commercial strategy, including scaling up manufacturing, expanded human safety trials and pivotal, non-clinical effectiveness studies in animals, through FDA licensure. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA.

Reportedly, Anthim has been developed under a National Institutes of Health (NIH) contract, using the BARDA Biodefense Medical Countermeasures Development Fund, as well as funding from the Department of Defense and the private sector. Elusys has completed two safety studies in humans and many studies demonstrating safety and efficacy in animal models.

Elusys has reported data from two animal studies as well as clinical safety studies highlighting the therapeutic potential for Anthim in the treatment of anthrax disease.

Elusys also reported results from an animal study that demonstrated that a single dose of Anthim provided up to 94% survival when administered to study subjects after symptoms of disease were present.

Anthim, given either by intravenous or intramuscular administration, provides a high level of survival when given immediately after anthrax exposure in animal models. In two dose-escalating human clinical safety studies, results show Anthim to be safe and well-tolerated at doses at or above the anticipated efficacious dose in humans.

Elizabeth Posillico, president and CEO of Elusys, said: “We are extremely pleased to extend our partnership with BARDA as we move into the final stages of drug development. This is a significant milestone for our company and the Anthim development program.

“Anthim consistently provides significant survival benefit in the treatment of anthrax infection in animal models and is safe and 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.”