Emergent BioSolutions initiates Phase I/II anthrax trial

Emergent BioSolutions, a biopharmaceutical company, has reported that the Phase I/II clinical trial for its anthrax immune globulin therapeutic candidate has commenced with the initial treatment given to the first subject.

The clinical trial will evaluate the safety and pharmacokinetics of anthrax immune globulin (AIG) in 120 healthy adult volunteers. The study is designed to evaluate three dose levels of a single intravenous infusion of AIG compared to Gamunex, a licensed immune globulin therapy for people with primary immunodeficiency or idiopathic thrombocytopenic purpura.

AIG is manufactured using the FDA-approved Gamunex process. In addition, a fourth cohort receiving two intravenous infusions of AIG or Gamunex at equivalent doses administered two days apart will be evaluated. The clinical trial will be conducted at SNBL Clinical Pharmacology Center, a clinical trial unit located in Baltimore, Maryland.

AIG, which is intended for the treatment of inhalational anthrax disease, is the company’s polyclonal therapeutic candidate developed using plasma collected from healthy donors, who have been vaccinated with Emergent’s BioThrax, the only vaccine approved by the FDA for the prevention of anthrax infection, the company said.

Stephen Lockhart, senior vice president of product development at Emergent BioSolutions, said: The initiation of this clinical trial is a significant milestone that marks our continued commitment to the AIG program and to the expansion of our anthrax product franchise. AIG is an integral component of our efforts to develop safe and effective treatments for patients to be used in the event of a biological attack.