AstraZeneca has reported positive data from the Phase III TACKLE clinical trial of its long-acting antibody (LAAB) combination, AZD7442, for treating Covid-19.
The antibody cocktail demonstrated a statistically significant decline in severe Covid-19 or mortality as against placebo in people suffering from mild-to-moderate symptomatic Covid-19 in the non-hospital setting.
Discovered by Vanderbilt University Medical Center, AZD7442 is a combination of tixagevimab (AZD8895) and cilgavimab (AZD1061).
In June last year, it was licenced to AstraZeneca.
The randomised, double-blind, placebo-controlled, multicentre Phase III trial analysed the safety and efficacy of a 600mg intramuscular dose of the antibody cocktail versus placebo for treating Covid-19 in outpatients.
The trial was carried out in 96 centres in countries including the UK, US, Brazil and Germany.
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It enrolled a total of 903 adult subjects aged 18 years and above, who were categorised in a 1:1 ratio to receive either the LAAB combination or placebo.
The composite of either severe Covid-19 or mortality from any cause by day 29 was the trial’s primary efficacy goal.
Findings showed that the trial met the primary goal, with AZD7442 offering a 50% lowered risk of developing severe disease or death versus placebo in the trial subjects.
Furthermore, in the AZD7442 group, 18 events were reported compared to 37 in the placebo group.
The antibody cocktail was also found to be well-tolerated in the study.
According to a prespecified analysis in subjects receiving the LAAB combination within five days of developing symptoms, the treatment lowered the severe disease or mortality risk by 67% versus placebo.
AZD7442 is the first-ever LAAB with Phase III trial results showing benefit in prophylaxis, as well as treatment of Covid-19, AstraZeneca noted.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.
“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months.”
Earlier this month, AstraZeneca submitted a request seeking the US Food and Drug Administration’s (FDA) emergency use authorization (EUA) for AZD7442 to prevent symptomatic Covid-19.