AstraZeneca Evusheld “Significantly” Cuts Risk of Severe COVID, Death in Phase 3 Trial

AstraZeneca said detailed results from a late stage outpatient treatment trial showed Evusheld provided statistically significant protection against progression to severe COVID-19 or death from any cause, compared to placebo, and outcomes were more favorable if the treatment was started early.

Evusheld is currently approved in the U.S., EU and U.K. to prevent COVID-19 in certain people.

"We are discussing the TACKLE data with regulatory authorities and continue to progress submissions in both treatment and prophylaxis indications to help combat COVID-19 on all fronts," said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca.

The British pharma giant said in a June 8 press release that results from the phase 3 trial, dubbed TACKLE, were published in The Lancet Respiratory Medicine.

The study was carried out in non-hospitalized adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less. About 90% of these participants were at high risk of progression to severe COVID-19 due to co-morbidities or age, according to the company.

"The TACKLE results show that one intramuscular dose of Evusheld can prevent these individuals from progressing to severe COVID-19, with earlier treatment leading to even better results," said Hugh Montgomery, the trial's principal investigator.

The company said data showed that a single 600mg intramuscular (IM) dose of Evusheld (tixagevimab/cilgavimab) significantly reduced the relative risk of progressing to severe COVID-19 or death (from any cause) by 50% through day 29, compared to placebo, in non-hospitalized patients with mild-to-moderate COVID who were symptomatic for seven days or less, which was the study's main goal.

Meanwhile, in people who received therapy within three days of symptom onset, Evusheld reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo, and the risk reduction was 67% when patients received Evusheld within five days of symptom onset, the company added.

The antibody cocktail also reduced the risk of respiratory failure, a secondary goal, by 72%, as three patients on Evusheld and 11 on placebo required measures such as mechanical ventilation or extracorporeal membrane oxygenation.

AstraZeneca (AZN) noted that Evusheld was generally well-tolerated in the study.