With FDA scrutinizing its data, AstraZeneca shows durability of COVID-preventing antibodies

Piece by piece, AstraZeneca is building the case for its COVID-19-preventing antibodies. The latest analysis moves the U.K. Big Pharma a step closer to a goal of achieving 12 months of protection with one dose of the long-acting antibody cocktail.

AstraZeneca’s pivotal trial of AZD7442 as a pre-exposure prophylactic met its primary endpoint in August. Back then, AstraZeneca linked the drug candidate to a 77% reduction in risk of symptomatic COVID-19. The analysis was based on 25 cases of symptomatic infection that happened by the May 9 data cutoff.

The new analysis issued today covers cases up to Aug. 29, enabling AstraZeneca to calculate that after a median of six months of follow-up, AZD7442 cut the risk of symptomatic COVID-19 by 83%. The placebo arm of the latest data set features five cases of severe COVID-19 and two deaths related to the virus. None of the recipients of AZD7442 died or developed severe COVID-19, suggesting the antibody cocktail may largely prevent the worst outcomes in the vulnerable target population.

AstraZeneca enrolled 5,197 people who were expected to respond poorly or be intolerant to COVID-19 vaccines or who were at increased risk of SARS-CoV-2 infection in the clinical trial. None of the participants were vaccinated at baseline. Participants can leave at any time to get vaccinated, potentially explaining why the six-month data set features 181 fewer people than the earlier analysis.

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The maintenance of protection out to a median of six months is a milestone in AstraZeneca’s attempt to establish AZD7442 as a viable option for people who cannot receive full protection from vaccines. The company made modifications including amino acid substitutions in an attempt to provide up to 12 months of protection.

That durability-focused work differentiates AZD7442 from other anti-SARS-CoV-2 antibodies such as the unmodified molecules in Regeneron’s REGEN-COV. AstraZeneca is set to come to market a long time after Regeneron, but the different approach gives it a shot at becoming the dominant antibody force in the COVID-19 prevention space. A filing for emergency use authorization is under review at the FDA.

AstraZeneca is also developing AZD7442 as a treatment for COVID-19 but faces more competition in that market. Last month, AZD7442 was linked to a 50% reduction in severe COVID-19 or death in ambulatory but high-risk patients, falling well short of the standard set by companies such as Regeneron. 

Now, an exploratory analysis of the study has suggested AZD7442 may be competitive if given within three days of the onset of symptoms. In that subgroup, AstraZeneca said AZD7442 spurred an 88% drop in the risk of severe COVID-19 or death.

On a call with journalists after the data drop Thursday morning, AZ's chief Pascal Soriot said that, while this drug had to be used within three days to work fully, he believed it can be done given the methof of use, a quick injection instead of an infusion, which is longer and more complex, and what he said were low risks of safety issues, notably when compared to some vaccines, which can require monitoring immediately after a shot.

There are also plans for trials in children, given the need to dampen down infection rates there, and help those most vulnerable who cannot get a vaccine.