AstraZeneca PLC (LSE:AZN)’s new long- acting antibody (LAAB) treatment halved the risk of death or catching severe COVID-19 in a phase III trial of people with mild symptoms, the pharma giant said today.
This trial, TACKLE, combined with results from a previous study PROVENT, showed that the treatment, called AZD7442, is both effective against COVID-19 infections as well as preventing the virus, said Astra.
In the trial, AZD7442 was administered in non-hospitalised patients with mild to moderate symptoms and produced a 50% reduction in severe COVID-19 or death compared to placebo, which met the primary endpoint.
Outpatients received a dose of 600mg of AZD7442 given by intramuscular (IM) injection.
In a prespecified analysis of participants who received treatment within five days of symptom onset, AZD7442 did even better and reduced the risk of developing severe COVID-19 or death (from any cause) by 67% compared to placebo.
AZD7442 is the first LAAB with Phase III data to demonstrate benefit in both prophylaxis and treatment of COVID-19 and is easily administered by IM injection, said AstraZeneca.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, added: “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.”
TACKLE included 903 participants in a 1:1 randomisation AZD7442 to placebo. The primary analysis was based on 822 participants.
Last week, AstraZeneca submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis (prevention) of COVID-19 based on the results of the earlier PROVENT trial, which reduced deaths by 77% in hospitalised and severely ill patients.
If granted, AZD7442 would be the first LAAB combination to receive an EUA for COVID-19 prevention.