Long Acting COVID-19 Antibody Combination Benefits Both Prophylaxis and Treatment
UK-based AstraZeneca announced on October 11, 2021, positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AZD7442, a long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients, with mild-to-moderate symptomatic COVID-19.
AZD7442 is the first LAAB with Phase III data to demonstrate benefit in preventing and treating COVID-19 and is easily administered by IM injection.
The TACKLE 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 had been symptomatic for seven days or less.
The LAAB (potentially effective up to 12 months) was generally well-tolerated in the trial.
A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.
In a prespecified analysis of 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, with nine events in the AZD7442 arm (9/253) and 27 in the placebo arm (27/251).
Hugh Montgomery, Professor of Intensive Care Medicine at University College London and TACKLE principal investigator, said in a press release: "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."
On October 5, 2021, the Company 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.
AZD7442 combines two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescence patients after SARS-CoV-2 virus infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein1 and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.