ZD7442 reduces risk of developing severe COVID-19 or death in Tackle phase-III outpatient treatment trial

Positive high-level results from the Tackle phase-III COVID-19 treatment trial showed that AstraZeneca’s AZD7442, a long-acting antibody (LAAB) combination, achieved a significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19, a statement from AstraZeneca informed.

A total of 90 per cent of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities, it added.

Further, according to the statement, the trial met the primary endpoint, with a dose of 600 mg of AZD7442 given by intra-muscular (IM) injection reducing the risk of developing severe COVID-19 or death (from any cause) by 50 per cent compared to placebo in outpatients who had been symptomatic for seven days or less. The trial recorded 18 events in the AZD7442 arm (18/407) and 37 in the placebo arm (37/415). The LAAB was generally well-tolerated in the trial.

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 per cent compared to placebo, with nine events in the AZD7442 arm (9/253) and 27 in the placebo arm (27/251), the statement mentioned.

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, as per the statement.

Speaking in this regard, Hugh Montgomery, Professor, Intensive Care Medicine, University College London, and Tackle principal investigator, said, “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 intra-muscular dose of AZD7442 could play an important role in helping combat this devastating pandemic.”

Addding to it, 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.”

TACKLE included 903 participants in a 1:1 randomisation AZD7442 to placebo. The primary analysis was based on 822 participants, the statement said.

It further mentioned that AstraZeneca will be discussing the data with health authorities. On 5th October, 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. The full results from Tackle will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.

Besides, it said that Tackle is a phase-III, randomised, double-blind, placebo-controlled, multi-centred trial assessing the safety and efficacy of a single 600mg IM dose of AZD7442 compared to placebo for the outpatient treatment of COVID-19. The trial was conducted in 96 sites in Brazil, Czech Republic, Germany, Hungary, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Ukraine, UK and US; 903 participants were randomised (1:1) to receive either AZD7442 (n = 452) or saline placebo (n = 451), administered in two separate, sequential IM injections.