LONDON: AstraZeneca reported on Monday that the antibody combination treatment given via an injection produced a “statistically significant” reduction in severe COVID-19 or mild to moderate death compared to non-hospitalized patients. Shown with symptomatic COVID-19.
The British-Swedish biopharmaceutical chief said: AZD7442 . Tackle for Phase III COVID-19 Treatment Trials showed that the treatment met the “primary endpoint”.
A single 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 for seven days compared with a placebo in outpatient or was symptomatic for less time.
“With continuing cases of severe COVID-19 infection around the world, there is a critical need for new therapies such as AZD7442 that can be used to protect vulnerable populations from COVID-19 and also help prevent the progression of serious disease. could do,” said Hugh Montgomery, professor of intensive care medicine at University College London, and TACKLE principal investigator.
“These positive results suggest that a convenient intramuscular dose of AZD7442 may play an important role in helping combat this devastating epidemic,” he said.
AZD7442 has been 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 readily administered by IM injection.
A total of 90 percent of the enrolled participants were at high risk of progression to severe COVID-19 from the population, including those with comorbidities.
Mene Pangalos, Executive Vice President, Biopharmaceuticals R&D, AstraZeneca, said: “These important results for AZD 7442, our long-acting antibody combination, add to the growing body of evidence for the use of this therapy, both in the prevention of and COVID-19 in both treatment.
“An early intervention with our antibodies can deliver a significant reduction in the progression of serious disease, with continued protection for more than six months.”
AstraZeneca said LAAB was generally well tolerated in the trial.
In a prescribed 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 a placebo.
The 1:1 randomization in Tackle AZD7442 consisted of 903 participants in placebo and the primary analysis was based on 822 participants.
AstraZeneca said it would discuss the data and its full findings with health officials at an appropriate time to be published in a medical journal.
Last week, the company announced that it had submitted a request to the US Food and Drug Administration (USFDA) for emergency use authorization for AZD7442 for the prophylaxis or treatment of COVID-19.