Emergent BioSolutions of Rockville, Md., has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to conduct a non-interference study to be used to support a post-exposure prophylaxis (PEP) indication for BioThrax, an adsorbed anthrax vaccine.
The agreement provides Emergent with up to $8.43 million in additional funding. The non-interference trial, targeted to commence in the fourth quarter of 2012, is expected to involve 120 healthy volunteers and is designed to demonstrate non-interference of BioThrax when administered in conjunction with antibiotics. Approval of a PEP indication would enable BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax only has a pre-exposure prophylaxis indication.
Separately, under its development contract with BARDA, Emergent has completed dosing and the last subject visit in a pivotal PEP immunogenicity and safety study evaluating a three-dose vaccination schedule for BioThrax. Data from this study, which involves 200 healthy volunteers, will also be used by the company in support of a PEP indication for BioThrax. The company anticipates preliminary data from this study will be available in the fourth quarter of 2012.