FDAnews
www.fdanews.com/articles/203197-astrazeneca-antibody-therapy-for-covid-19-fails-in-late-stage-trial

AstraZeneca Antibody Therapy for COVID-19 Fails in Late-Stage Trial

June 16, 2021

AstraZeneca’s monoclonal antibody cocktail, AZD7442, failed to prevent symptomatic COVID-19 infection in a late-stage study of individuals recently exposed to the SARS-CoV-2 virus.

In the 1,121-participant phase 3 trial, a single dose of AZD7442 reduced the risk of developing symptomatic COVID-19 by 33 percent when compared against placebo, but the response was not deemed statistically significant.

AZD7442 combines two antibodies, tixagevimab and cilgavimab, derived from convalescent COVID-19 patients. Discovered by researchers at Vanderbilt University and licensed to AstraZeneca in June 2020, the monoclonal antibodies are meant to bind to the SARS-CoV-2 spike protein and mimic the body’s natural disease-fighting antibodies.

The findings mark a serious setback for AstraZeneca, which has agreements totaling $726 million to supply the U.S. government with up to 700,000 AZD7442 doses this year, pending FDA authorization or approval. The payments are contingent on approval or authorization.

The Anglo-Swedish drugmaker is now awaiting data from several additional trials evaluating AZD7442 for treating or preventing COVID-19 and hoping those results could revive the antibody cocktail’s prospects as a viable treatment option.

“While this trial did not meet the primary endpoint against symptomatic illness, we are encouraged by the protection seen in the [polymerase chain-reaction] negative participants following treatment with AZD7442,” said Mene Pangalos, AstraZeneca’s executive vice president for biopharmaceuticals research and development. — Jason Scott