BARDA awarded Elusys Therapeutics a contract to develop a treatment for inhaled anthrax that could span five years and total $143 million. The first year of the contract, called the base year, is valued at $16.8 million.
Elusys Therapeutics will continue development of a medication called Anthim specifically for inhaled anthrax. The aim is to produce this mAb in the laboratory by a single group of genetically identical cells.
The BARDA contract includes scaling up manufacturing, formulation chemistry studies to determine how much of the drug is needed to be effective, additional human safety trials, and pivotal, nonclinical effectiveness studies in animals toward licensure through the FDA. Anthim has FDA fast track and orphan drug designations.
The drug has been developed under an NIH contract since 2007 utilizing the BARDA biodefense medical countermeasures development fund. To date Elusys reports that it has received more than $44 million from NIAID/BARDA and the DoD in support of Anthim and the company’s heteropolymer antibody™ technology. These funds along with private sector financing has allowed the firm to manufacture Anthim, conduct two Phase I trials, and undertake safety and efficacy studies in animal models.