New monitoring data suggests that AstraZeneca’s long-acting antibody may protect populations at high risk of contracting Covid-19 for up to six months, thus strengthening its case as a form of ‘passive immunization’ or “passive vaccination”.
At the six-month deadline for the phase III PROVENT trial, investigators tracked an 83% reduction in the risk of symptomatic Covid-19 after a dose of the antibody in 4,991 volunteers. The company did not specify the number of cases in both arms, noting only that there had been no serious illness or death related to Covid in the AZD7442 arm and two additional cases of severe Covid-19 in the placebo arm (for a total of five serious cases and two related deaths).
Almost two months after the initial read, the update was released alongside a new analysis of the TACKLE trial, which tested AZD7442 as a treatment and showed that, given within three days of onset of symptoms, it can reduce the risk of serious illness or death by 88% – a significant jump from the 50% number previously reported when treatment was given within seven days.
Together, AstraZeneca said, they paint a more complete picture of AZD7442, which he first licensed to Vanderbilt, as a significant addition to the arsenal.
“AZD7442 is the only long-acting antibody with phase III data to demonstrate benefit in both pre-exposure prophylaxis and treatment of COVID-19 with a dose,” said Mene Pangalos, vice-president executive chairman of biopharmaceutical R&D in a declaration.
In a recent interview with Terminal news, Pangalos pointed out how the long-acting property of the drug sets it apart from other antibodies. Eli Lilly, Regeneron, and Vir / GlaxoSmithKline have all secured emergency use authorizations for their therapies, with use increasing amid new flare-ups from the Delta variant and breakthrough cases.
“Others talk about prophylaxis, but they talk about monthly administration,” he said. “We talk, potentially, at most twice a year, hopefully it will be once a year. And so almost sort of, you know, passive immunization or passive immunization. “
The FDA is currently reviewing a case for EUA for prophylaxis.
This is particularly relevant considering that PROVENT sought to recruit immunocompromised participants – people with multiple sclerosis, for example, or cancer. These people, estimated at around 2 to 3% of the population, are less protected by vaccination.
“It is important to note that six months of protection has been maintained despite the rise of the Delta variant among those high-risk participants who may not respond adequately to vaccination,” said Hugh Montgomery, principal investigator and professor of critical care medicine at University College London.
On the treatment side, TACKLE also targeted patients at high risk of progression to severe Covid-19 for recruitment – with 90% of participants in this category. Again, there was no breakdown of the number of cases in each group.
The new exploratory analysis suggested that when given sooner after symptom onset, a single dose of AZD7442 may better prevent these serious effects much better than placebo in outpatients. “You can deal with an oral antiviral, that’s great,” Pangalos said. “Now you can treat with an antibody, or you can also treat with ours later, and you won’t just be treated for the two weeks you have symptoms. You will be treated for the next 12 months in terms of prevention.
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