On October 11, 2021, AstraZeneca announced the topline results from their Phase III TACKLE trial in outpatient treatment with AZD7442 for patients with early, mild to moderate COVID-19.
The trial met the primary endpoint, demonstrating a significant reduction in severe COVID-19 or death compared to placebo.
AZD7442, a combination of two anti-SARS-CoV-2 monoclonal antibodies (mAbs), given IM (intramuscularly) reduced the risk of developing severe COVID-19 or death by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.
If given within five days, the reduction jumped to 67%. This emphasizes the critical importance of early intervention when the virus is rapidly replicating but the disease has not yet entered the severe inflammatory phase. Anti-viral medications such as mAbs are less likely to be helpful when inflammation is the major problem.
A total of 90% of participants enrolled were at high risk of progression to severe COVID-19, including those with co-morbidities. We do not yet know how many were immunocompromised.
One should never compare across trials, but I want to remind readers of the data from two other antibodies given by infusion (intravenous or subcutaneous) compared to this simpler, less resource intensive IM injection.
Regeneron has already received EUA (emergency use authorization) for REGN-COV2 after that anti-SARS-CoV-2 antibody cocktail was shown to result in a 70% drop in coronavirus-related hospitalization and all-cause death. Brii Biosciences’ antibody reduced hospitalizations and deaths by 78%.
Here is some reaction to this news:
Dr Kovilen Sawmynaden, Principal Scientist, LifeArc:
“…potent antibody combinations such as these do provide valuable tools for those patients in need of ‘instant immunity’ and/or in high-risk groups, who haven’t responded to vaccines. The modification of this antibody to provide a long-lasting effect is particularly welcome.”
He is talking about the value of mAbs in populations such as CLL patients.
Here is the official press release: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html
This is welcome news. The more antibodies available that protect us from COVID-19 the better.
The long-acting and IM method of administration are significant advantages. Hopefully EUA is coming soon for AZD7442. It is already in front of the FDA for Pre-Exposure Prophylaxis (PrEP).
As one of my doctor’s said, COVID-19 is not our friend, so we need all the armor we can muster.
Please use the CLL Society’s COVID-19 ACTION PLAN to prepare should you be exposed or test positive for COVID-19. Please plan ahead and move fast.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-Founder, Executive VP and Chief Medical Officer