Anthrax vaccine NuThrax enters Phase II clinical trial
NuThrax, also known as AV7909, consists of a combination of Anthrax Vaccine Adsorbed and the adjuvant CPG 7909. Preliminary data from the NuThrax study are expected to be available in the fourth quarter of 2013.
"Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which supports the near-term goal and priority of the U.S. Department of Health and Human Services to develop next generation anthrax vaccines with advanced characteristics such as requiring fewer doses and generating an enhanced immune response," Adam Havey, the president of the biodefense division at Emergent BioSolutions, said. "We thank HHS for their continued trust and partnership as we work together to accomplish elements of its Public Health Emergency Medical Countermeasures Enterprise Implementation Plan set forth to strengthen the nation's biodefense capabilities."
Emergent BioSolutions, Inc., currently the provider of the only U.S. Food and Drug Administration approved anthrax vaccine, has submitted the Clinical Study Report for the Phase I test of NuThrax to the FDA. The study analyzed the safety and immunogenicity of the vaccine for post exposure prophylaxis.
The Phase II clinical trial will be conducted with support from the U.S. National Institute of Allergy and Infectious Diseases, which operates under the U.S. National Institutes of Health and HHS. The Phase I trial was conducted with support from NIAID and the U.S. Biomedical Advanced Research and Development Authority, which also a part of HHS.