Emergent BioSolutions announces new clinical trial

Emergent BioSolutions has announced the initiation of a Phase 2 clinical trial for NuThraxTM (Anthrax Vaccine Absorbed with CPG 7909 Adjuvant).

It is also known as AV7909 and is developed as part of Emergent's anthrax franchise and consists of Anthrax Vaccine Adsorbed and the novel immunostimulatory adjuvant CPG 7909.

The randomised, parallel-group, active-controlled, double-blind study hopes to review the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection by using two and three dose immunization schedules and two dose levels.

The work will take place over multiple sites in the US, with 168 healthy adult volunteers set to be enrolled.

Support for the research will come from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.

Adam Havey, EVP and president of the biodefense division at Emergent BioSolutions, said: "Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which supports the near-term goal and priority of the US 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.

"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."

Emergent has forwarded a Clinical Study Report for the Phase 1 study to the US Food and Drug Administration, which reviewed the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection with a two dose immunization schedule and four formulations.

Recently, Emergent's TRU-016 drug for the treatment of chronic lymphocytic leukaemia (CLL) has been granted orphan medicinal product designation.

The move means that the solution can qualify for specific development and commercial incentives, such as protocol assistance, access to centralised authorisation procedures, reduced fees for regulatory activities and ten years of market exclusivity.

Posted by Neil Clark