Emergent Biosolutions announces results of Phase 3 Biothrax study
The clinical trial looked at the safety and immunogenicity of three-dose BioThrax. The primary and key secondary points were met in the trial, meaning it was shown to be safe and immunogenic. The results of the study were published in the July issue of Clinical and Vaccine Immunology.
"Emergent's on-time completion of this study and submission of our clinical study report represents a key milestone in our BioThrax PEP development program," Adam Havey executive vice president and president of Emergent's biodefense division, said. "These data represent the culmination of a multi-year effort aimed at evaluating the use of BioThrax for PEP. This work is an excellent example of the partnership between industry and the U.S. Government agencies including BARDA FDA the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention."
BioThrax is the only FDA-licensed vaccine that prevents anthrax. BioThrax is capable of preventing anthrax in adults who have a high risk of exposure, however, the vaccine will not work after the person has already been exposed.
Emergent BioSolutions is a pharmaceutical company that offers specialized products to healthcare providers and governments. Its products are aimed at tackling medical needs and emerging health threats.