Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase 2 clinical trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. NuThrax, a next generation vaccine being developed as part of Emergent's anthrax franchise, consists of Anthrax Vaccine Adsorbed in combination with a novel immunostimulatory adjuvant, CPG 7909.
"Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which supports the near-term goal and priority of the U.S. Department of Health and Human Services (HHS) to develop next generation anthrax vaccines with advanced characteristics such as requiring fewer doses and generating an enhanced immune response," said Adam Havey, EVP and president of the biodefense division at Emergent BioSolutions. "We thank HHS for their continued trust and partnership as we work together to accomplish elements of its Public Health Emergency Medical Countermeasures Enterprise Implementation Plan set forth to strengthen the nation's biodefense capabilities."
The Phase 2 clinical trial, a randomized, parallel-group, active-controlled, double-blind study, is designed to evaluate the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two and three dose immunization schedules and two dose levels. The study is being conducted in multiple sites within the U.S. and plans to enroll 168 healthy adult volunteers. Preliminary data from this study are expected in the fourth quarter of 2013.
Emergent has submitted to the U.S. Food and Drug Administration the Clinical Study Report for the Phase 1 study, which evaluated the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using a two dose immunization schedule and four formulations.
This Phase 2 clinical trial is being conducted with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS, under development contract number HHSN272201000035C. The Phase 1 trial was conducted with support from a development contract jointly administered under contract number HHSN272200800051C by NIAID and the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR), HHS.