Emergent BioSolutions Plans Pivotal Trial of Anthrax Immune Globulin

Emergent BioSolutions announced it has submitted an investigational new drug application to the FDA for its anthrax immune globulin (AIG) product candidate.

AIG is a therapeutic treatment for patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. The company expects to initiate a Phase I pivotal clinical trial evaluating the safety and pharmacokinetics of AIG in 105 healthy volunteers.

Emergent anticipates that the clinical trial for its AIG candidate will be completed within approximately one year from its commencement date and that no additional clinical trials will be required prior to submitting an application to FDA for marketing approval.

The company, which is relying on the FDA animal rule in developing its AIG candidate, expects to conduct pivotal efficacy studies in two animal models, with the timing of those studies dependent on completion of the development of the models in collaboration with the U.S. government. Emergent believes that favorable data from these clinical and nonclinical studies would be sufficient to support an application to the FDA for approval of its AIG candidate.

Last year the NIH's National Institute of Allergy and Infectious Diseases agreed to provide funding to the company of up to $3.7 million to support pivotal animal studies and for the development and validation of product assays.