Emergent BioSolutions Inc announced that its Investigational New Drug (IND) application, to commence a phase-I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared US Food and Drug Administration (FDA) review. The phase-I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.

"Emergent is committed to advancing its anthrax franchise, which includes both vaccines and therapeutics that address the anthrax threat," said Stephen Lockhart, MRCP, senior vice president product development of Emergent BioSolutions. "The end goal is to strengthen the nation's arsenal of medical countermeasures and provide products that will support the government's biopreparedness efforts."

The phase-I clinical trial is designed as a randomized, double-blind, placebo-controlled, dose-escalation study involving 50 healthy volunteers. Emergent anticipates the overall duration of the trial to be 15 months, with dosing of all subjects expected to be completed within 11 months of initiation of the clinical trial.

Emergent has received US$ 24.3 million in development funding from the United States Government to support the development of its monoclonal antibody as a therapeutic for inhalation anthrax. This study is being funded by the Biomedical Advance Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), under contract No. HHSN272200800040C.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body's immune system to prevent or treat disease.