BARDA, DARPA support AstraZeneca through phase 1 trial of COVID-19 therapeutic

The Biomedical Advanced Research and Development Authority (BARDA) and the Defense Advanced Research Projects Agency (DARPA) have reached an interagency agreement with AstraZeneca to support phase 1 clinical development of a monoclonal antibody combination therapy for use against COVID-19.

This assistance will cover both a phase 1 clinical trial and the manufacturing of the investigational product for testing. AstraZeneca, which recently signed a deal granting it an exclusive license for six anti-SARS-CoV-2 antibodies identified by researchers at Vanderbilt University, intends to start a phase 1 trial of a COVID-19 antibody therapy within two months.

The body generates antibodies to fight off infections. Monoclonal antibodies, like those used in this case, are laboratory synthesized therapies that can be manufactured in large quantities and used to negate viruses. A combination of such antibodies targeting the SARS-CoV-2 virus — the virus that causes COVID-19 — could conceivably be used to both prevent infection and to treat existing infections.

This is not a treatment approved by the U.S. Food and Drug Administration (FDA), though. There remain no FDA-approved treatments or vaccines for COVID-19, a fact that has spurred the Department of Health and Human Services to label the need for therapeutic and prophylactic antibody therapies urgent.