Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease. The Phase I clinical trial, involving 50 healthy volunteers, is a randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate.

"Emergent is excited about the continued progress of its anthrax monoclonal antibody therapeutic," said Stephen Lockhart, MRCP, senior vice president product development of Emergent BioSolutions. "This milestone reaffirms Emergent's commitment to leading the development of medical countermeasures that address inhalational anthrax as a biological threat."

Emergent received clearance of its Investigational New Drug application from the U.S. Food and Drug Administration to proceed with this Phase I clinical trial in May of this year.

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 Inc.