Emergent BioSolutions, Inc.'s IND for anthrax antibody clears FDA review

Officials with Emergent BioSolutions, Inc., announced on Monday that the company's Investigational New Drug application to begin clinical trials for an anthrax antibody has cleared review by the U.S. Food and Drug Administration.

The Phase 1 clinical trial, officials said, will examine the safety of the company’s monoclonal antibody, which is being developed as a, “a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease."

The monoclonal antibody was found to be effective in pre-clinical therapeutic studies.

“Emergent is committed to advancing its anthrax franchise, which includes both vaccines and therapeutics that address the anthrax threat,” Stephen Lockhart, Emergent BioSolutions, Inc.'s senior vice president of product development, said. “The end goal is to strengthen the nation's arsenal of medical countermeasures and provide products that will support the government's biopreparedness efforts.”

The Phase 1 clinical trial will involve 50 healthy volunteers and will likely last 15 months, according to Emergent BioSolutions, Inc.'s estimates.

Emergent BioSolutions, Inc., has received $24.3 million from the U.S. government to support monoclonal antibody to combat inhalation anthrax.

The study will be funded by the Biomedical Advance Research and Development Authority, the National Institute of Allergy and Infectious Diseases, the National Institutes of Health and the Department of Health and Human Services.

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