An antibody combination treatment delivered through an injection has shown a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19, AstraZeneca reported on Monday. The British-Swedish biopharmaceutical major said its TACKLE Phase III COVID-19 treatment trial for AZD7442 had shown that the treatment met the primary endpoint.
A dose of 600mg of AZD7442 given by intramuscular (IM) injection reduced the risk of developing severe COVID-19 or death (from any cause) by 50 percent, compared to placebo in outpatients who had been symptomatic for seven days or less. 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, said Hugh Montgomery, Professor of Intensive Care Medicine at University College London, and TACKLE principal investigator.
These positive results show that a convenient intramuscular dose of AZD7442 could play an important role in helping combat this devastating pandemic, he said. AZD7442 is dubbed as the first long-acting antibody (LAAB) with Phase III data to demonstrate benefit in both prophylaxis (prevention) and treatment of COVID-19 and is easily administered by IM injection.
A total of 90 percent of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with comorbidities. 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. The LAAB was generally well tolerated in the trial,” AstraZeneca said.
In a pre-specified 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 percent compared to placebo.
TACKLE included 903 participants in a 1:1 randomisation AZD7442 to placebo and the primary analysis was based on 822 participants. AstraZeneca said it will be discussing the data with health authorities and its full findings to be published in a medical journal in due course. Last week, the company had announced that it submitted a request to the US Food and Drug Administration (USFDA) for Emergency Use Authorisation for AZD7442 for prophylaxis or treatment of COVID-19.