AstraZeneca has announced positive results from a Phase III trial evaluating its long-acting antibody (LAAB) combination AZD7442 in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.
In the Phase III TACKLE trial, a total of 90% of participants enrolled were from populations with a high-risk of progressing to severe COVID-19, including individuals with co-morbidities.
The late-stage trial hit its primary endpoint, with AZD7442 600 mg given by intramuscular injections (IM) 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.
On top of that, a prespecified analysis of participants who received treatment within five days of symptom onset showed that AZD7442 reduced the risk of developing severe COVID-19 or death by 67% compared to placebo.
“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.
“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” he added.
AZ has already submitted a request to the FDA seeking an emergency use authorisation (EUA) for the LAAB combination for prophylaxis of COVID-19.