Emergent BioSolutions, Inc., announces Phase 2 study of Biothrax in conjunction with antibiotics
The non-interference study will support a supplemental Biologicals License Application seeking licensure of a post-exposure prophylaxis indication for BioThrax to be used in combination with antibiotics with those suspected of having been exposed to anthrax spores. BioThrax is currently only licensed for a pre-exposure prophylaxis indication.
"Emergent continues to advance its BioThrax Post-Exposure Prophylaxis program to enhance the clinical utility of BioThrax, the only vaccine licensed by the U.S. Food and Drug Administration for the active immunization against anthrax disease," Adam Havey, the executive vice president and president of the biodefense division at Emergent BioSolutions, said. "Inhalation anthrax is highly lethal when left untreated. Through our partnership with the Biomedical Advanced Research and Development Authority, we are exploring how our vaccine can fit in the current PEP treatment regimen, which consists of only oral antibiotics. We remain committed to working in partnership with BARDA to advance critical countermeasures that help ensure the nation's preparedness."
The randomized, open label Phase 2 study will evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic both prior to and following the three dose BioThrax administration series.
A total of 120 healthy adult volunteers will be enrolled in the study, which is being conducted in multiple sites in the U.S.