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AstraZeneca will move to seek regulatory approval of its antibody cocktail after a study showed the drug significantly reduced the risk of developing symptomatic Covid-19.
That would make it the first long-acting drug that is not a vaccine that has demonstrated prevention of the disease in a clinical trial.
The Anglo-Swedish drugmaker said on Friday that its AZD7442 antibody combination showed a 77 per cent reduction in the development of symptomatic Covid compared with placebo. There were no severe Covid cases or deaths in those treated with the drug, while the placebo arm accrued three cases of severe disease, including two deaths.
More than three-quarters of the 5,197 late-stage trial participants had comorbidities, the company said, including conditions that have been reported to cause a lowered immune response to vaccination. Of these, 5,172 were not infected with coronavirus at baseline.
The drug could be more suitable for patients for whom a vaccine is not recommended. The drug cocktail offers up to a full year of protection from Covid and is delivered by intramuscular injection. The drug was well-tolerated, AstraZeneca said, and adverse events were “balanced” between the two trials.
Mene Pangalos, the drugmaker’s chief of research and development, said “additional approaches” were needed for those that Covid vaccines could not protect. He said the company was “very encouraged” by the data released on Friday.
AstraZeneca said preliminary cell studies showed the cocktail neutralises emergent viral variants, including Delta.
While there are a number of safe and effective vaccines approved across the world, including one made by Oxford university and AstraZeneca, the quest to find effective treatments, especially those that work to prevent symptomatic Covid, has been less successful. Most treatments either target viral replication directly, or the body’s immune overreaction in severe cases, but they are all approved for treatment after exposure or when infection is confirmed, and not before.
A trial for the same antibody cocktail in June had failed to meet its primary endpoints, but it was devised to study the combination in patients who had already been exposed to the virus. AstraZeneca said then it was hopeful the drug could work to prevent disease if it was given early enough.
AstraZeneca has a deal with the US to supply up to 700,000 doses of the treatment for up to $726m.
Antibody cocktails are difficult to administer and expensive to make, making them cost-effective only if their effects are significant.
Prophylactic approaches in infectious disease have been shown to be game-changers, including for HIV, where existing and licensed treatments can lower the risk of contracting infection by up to 99 per cent.
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