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A phase 3 trial met the primary endpoint, and the long-acting antibody combination reduced symptoms or death by 67% for patients compared with those who took a placebo.
AZD7442 (AstraZeneca), a long-acting antibody combination (LAAB), has been shown to reduce severe COVID-19 or death compared with a placebo in non-hospitalized individuals with mild to moderate symptomatic COVID-19, the company said in a statement.
“With continued cases of serious COVID-19 infections across the globe, there is a significant need for new therapies like AZD7442 that can be used to protect vulnerable populations from getting COVID-19 and can also help prevent progression to severe disease. These positive results show that a convenient intramuscular dose of AZD7442 could play an important role in helping combat this devastating pandemic,” Hugh Montgomery, MD, professor of intensive care medicine at the University College London, said in the statement.
The TACKLE phase 3 trial met the primary endpoint for reducing the risk of severe COVID-19 or death for the 600-mg dose of AZD7442 by intramuscular injection compared with a placebo.
For individuals who received treatment within 5 days of symptom onset, the LAAB reduced symptoms or death by 67% compared with those treated with the placebo.
The LAAB was well-tolerated in the trial.
“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19. An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” Mene Pangalos, PhD, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said in the statement.
AZD7442 is the first LAAB with phase 3 data to demonstrate the benefit of both prophylaxis and treatment of COVID-19.
Full results from the TACKLE trial will be submitted for publication in a peer-reviewed medical journal and presented at an upcoming medical meeting.
Reference
AZD7442 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial. AstraZeneca. News release. October 11, 2021. Accessed on October 12, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html