Emergent BioSolutions, Inc. begins inhaled anthrax therapeutic trial

Emergent BioSolutions, Inc. has begun dosing its first subjects in a Phase I clinical trial for its anthrax monoclonal antibody therapeutic.

The fully human monoclonal antibody product candidate, Emergent BioSolutions, Inc. says, is being developed as a parental post-exposure therapeutic to treat symptoms of inhalational anthrax.

The Phase I clinical trial consists of 50 healthy volunteers taking part in a randomized, double-blind, placebo-controlled dose escalation study. The study is designed as a means of evaluating the safety and pharmacokinetics of the monoclonal antibody candidate.

"Emergent is excited about the continued progress of its anthrax monoclonal antibody therapeutic," Stephen Lockhart, the senior vice president of product development at Emergent BioSolutions, Inc., said. "This milestone reaffirms Emergent's commitment to leading the development of medical countermeasures that address inhalational anthrax as a biological threat."

In May, the U.S. Food and Drug Administration gave Emergent BioSolutions, Inc. clearance for its Investigational New Drug Application to begin the Phase I clinical trial, which is being funded by the Biomedical Advance Research and Development Authority and the National Institute of Allergy and Infectious Diseases, the National Institutes of Health and the Department of Health and Human Services

Emergent BioSolutions inc., a biopharmaceutical company, is the maker of BioThrax, the only vaccine approved by the FDA for the prevention of anthrax infection.

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National Institutes of Health

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