Emergent BioSolutions submitted an IND application for its Anthrax Immune Globulin (AIG) candidate. The product is being developed as a single-dose intravenous therapeutic for treatment of patients with symptoms of anthrax disease resulting from the release of anthrax toxins into the body.
Pending the standard 30-day FDA review period, the company expects to initiate a clinical trial to evaluate the therapy’s safety and pharmacokinetics in 105 healthy volunteers.
Emergent BioSolutions anticipates that the clinical trial for its AIG candidate will be completed within approximately one year from its commencement. The company, which is relying on the FDA animal rule in developing its AIG candidate, will conduct efficacy studies in two animal models. The timing of those studies will depend on completion of the models in collaboration with the U.S. government.
If successful, the company expects AIG to be prescribed either as a monotherapy or in conjunction with an antibiotic.
Emergent BioSolution’s biodefense portfolio includes BioThrax®, reportedly the only FDA-licensed vaccine against anthrax infection.