Positive high-level results from the TACKLE phase 3 COVID-19 treatment trial showed AstraZeneca’s AZD7442, a long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.
A total of 90% of participants enrolled were from populations at high risk of severe COVID-19, including those with co-morbidities.
The trial met the primary endpoint, with a dose of 600mg of AZD7442 given by intramuscular injection reducing the risk of developing severe COVID-19 or death (from any cause) by 50% compared to placebo in outpatients who have had symptoms for seven days or less. In the trial, out of 407 participants receiving AZD7442, there were 18 events. Out of the 415 participants receiving placebo in the trial, there were 37 events.
In participants who received treatment within five days of symptom onset, AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 67% compared to placebo. In this trial, out of 253 participants receiving AZD7442, there were 9 events. Out of the 251 participants receiving placebo in the trial, there were 27 events.
AZD7442 is the first LAAB with phase 3 data to demonstrate benefit in both prophylaxis and treatment of COVID-19 and is administered by intramuscular injection.
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, and TACKLE principal investigator, said: “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.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “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.”
On 5 October 2021, AstraZeneca announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19.