AstraZeneca's coronavirus antibody drug cocktail begins human tests.
AstraZeneca has dosed the first participant in a Phase 1 trial of a combination of coronavirus antibody drugs, medicines being developed by the British drugmaker and others to either prevent or treat infections from SARS-CoV-2.
The two-drug antibody combination, known as AZD7442, is being tested in a placebo-controlled study of 48 volunteers between 18 and 55 years old, with results expected later this year. AstraZeneca licensed the antibodies from Vanderbilt University and published results from an animal study in Nature in July.
AstraZeneca is now the third company to bring a coronavirus antibody drug into human testing, following Regeneron Pharmaceuticals and Eli Lilly, whose programs are further along. While engineered antibodies have the potential to be a critical tool against the coronavirus, trial timelines have reportedly slipped, which could shorten their window if a broadly effective vaccine becomes available.
The trial AstraZeneca has announced makes it a unique player in the fight against COVID-19. It's the only company thus far to bring both an experimental vaccine and antibody drug into human studies.
Much of the attention has gone to AstraZeneca's vaccine, a shot developed by the University of Oxford that is at the forefront of the global race for a preventive treatment. It's one of just three vaccines to advance to late-stage trials, and a report this past weekend indicated that the White House is considering it as a candidate for an emergency use authorization from the Food and Drug Administration as early as next month. (AstraZeneca, according to Politico, denied any talks were taking place.)
But the British firm is now firmly entrenched into the burgeoning coronavirus antibody drug race as well. The pace is being set by Regeneron and Eli Lilly, which both have experimental treatments in late-stage trials. But AstraZeneca is among the next wave of coronavirus antibody developers, which also include Vir Biotechnology, AbbVie, Amgen, and startup Adagio Therapeutics. AstraZeneca is the first of that group to get to human trials.
Coronavirus antibody drugs are meant to mimic the effects of the disease-fighting molecules our bodies produce to fight infection. Infused, likely at a clinic, they act fast and might either protect someone from COVID-19 or treat someone who has the disease. They could be particularly useful for the elderly or people with weak immune systems, who are more vulnerable to COVID-19 and less likely to respond to a vaccine. Developers have also touted them as a bridge to an effective vaccine, given their potentially unique flexibility, but haven't yet disclosed results from a human trial.
Lilly's and Regeneron's antibody drugs, like coronavirus vaccines, have advanced at a record pace and, at least thus far, haven't been tripped up by any notable safety problems. But their progress also hasn't been as fast as the companies once hoped.
Both aimed to have their antibodies ready for initial use by August and September, respectively. however results are taking longer to accrue. A New York Times report detailed problems the companies are having running their trials — issues ranging from enrolling the right types of patients to getting timely results from diagnostic tests.
Antibody drugs also haven't gotten nearly as much financial support from government entities as vaccines, which have been supported by billions of dollars in funding to prepare for widespread distribution. The Biomedical Advanced Research and Development Authority, for instance, has committed as much as $1.2 billion to develop and produce the vaccine AstraZeneca licensed from the University of Oxford.
BARDA's grant for AstraZeneca's antibody work, by comparison, is just under $24 million. Regeneron, which got $450 million from the U.S. government, recently cut a deal with Roche to help produce and distribute its coronavirus antibody drugs.
Each coronavirus antibody developer is taking a different approach. Lilly is testing single engineered antibodies, since they're less complex to make than a combination. Regeneron is advancing a cocktail, believing a two-drug approach will be more effective against SARS-CoV-2.
AstraZeneca is using a combination of antibodies as well, but unlike Regeneron, is tweaking them so their effects last "at least" six months, the company said in a statement.
Author:Ben Fidler
Published: https://www.biopharmadive.com/news/astrazeneca-covid-19-antibody-phase-1-trial/584071/