The Biomedical Advanced Research and Development Authority (BARDA) will provide technical assistance on a Phase 3 clinical trial underway to evaluate the drug lenzilumab being developed by Humanigen.
The drug is designed to prevent or treat an immune hyper-response called a cytokine storm. Cytokine storm is a severe immune reaction in which the body releases a high level of cytokines in the blood in a short time frame, which can result in lung injury. The reaction is associated with COVID-19 infections. It can be triggered by the acute respiratory distress syndrome in severe cases of COVID-19. Lenzilumab is being evaluated as a treatment for cytokine storm to prevent lung damage.
BARDA will provide subject matter expertise for statistical analysis, and manufacturing and regulatory activities to support drug development in advance of a potential Emergency Use Authorization (EUA) for COVID-19. The support comes through a Cooperative Research and Development Agreement (CRADA) with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).
Lenzilumab was selected by the National Institutes of Health for its ACTIV-5 “Big Effect Trial.” ACTIV refers to the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) – a public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of some of the most promising treatments and vaccines to treat or prevent SARS-COV-2 infections.