AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint

Astrazeneca announced on Oct. 11, 2021, that a Phase III clinical trial (TACKLE) investigating the long-acting antibody (LAAB) combination, AZD7442, had met its primary endpoint. According to a company press release, AZD7442 is the only LAAB that has demonstrated effectiveness in both treating and preventing COVID-19.

In the Phase III trial, AZD7442, a combination of tixagevimab (AZD8895) and cilgavimab (AZD1061), was studied for the ability to block the binding of SARS-CoV-2 virus to host cells to protect against infection. The trial included 903 participants with a confirmed SARS-CoV-2 infection in a 1:1 randomization of AZD7442 to placebo, 822 of which were used in the primary analysis. Ninety percent of the patient pool came from populations with a high risk of progression to severe COVID-19, including those with comorbidities.

In the trial, patients were dosed with 600 mg of AZD7442 (n=452) or saline placebo (n=451) through intramuscular injection. There were 18 events (severe COVID-19 or death) among patients given AZD7442 (18/407) and 37 among patients given the placebo (37/415), demonstrating a 50% reduction in risk among the AZD7442 population. The LAAB was generally well tolerated.

An analysis of participants who received treatment within five days of symptom onset found that AZD7442 reduced the risk of severe COVID-19 or death by 67% compared to placebo. There were nine events among participants given AZD7442 (9/253) and 27 among participants given the placebo (27/251).

“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19,” said Mene Pangalos, executive vice-president of BioPharmaceuticals R&D at AstraZeneca, in the press release. “An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months.”

The company announced that they had requested an emergency use authorization of AZD7442 from FDA for prophylaxis of COVID-19 on Oct. 5th, 2021. Full results from TACKLE will be published in as of yet unnamed peer-reviewed medical journal.

Source: AstraZeneca