AstraZeneca is back in the COVID-19 game with new data for its antibody cocktail, Evusheld. While it's existing authorizations cover the prophylactic setting, the latest results from the Big Pharma puts the drug in contention as a treatment for patients with mild-to-moderate disease.
The company posted data from a phase 3 trial in the Lancet Respiratory Medicine, showing that the medicine reduced the risk of progression to severe COVID or death from any cause by 50% compared to placebo at day 28, which was the trial's primary endpoint. The drug was tested in non-hospitalized adults with mild-to-moderate COVID-19, and 90% of the patients were at risk of progressing to severe COVID.
While the study, dubbed Tackle, included patients who had symptoms for seven days or less, it was designed with a pre-specified analyses to assess patients who received the intramuscular injection within three days of symptom onset. In this group, Evusheld reduced the risk of severe COVID or death from any cause by 88% compared to placebo, and the risk reduction was 67% when participants received Evusheld within five days of symptom onset.
Regulatory submissions are progressing worldwide, AZ said. Evusheld has marketing authorization in the EU and emergency use authorization in the U.S. as a pre-exposure prophylaxis of COVID.
In terms of secondary endpoints, Evusheld decreased the risk of respiratory failure by 72%, with three participants on Evusheld requiring mechanical ventilation compared to 11 placebo participants.
Adverse events hit the placebo group more than the Evusheld group, or 36% versus 29%. COVID-19 pneumonia occurred in 11% of the placebo group and 6% in the Evusheld group. There were six reported deaths in the placebo group and three in the Evusheld group.
The trial was conducted with 903 participants at 95 sites across the U.S., Latin America, Europe and Japan.
AstraZeneca also touted the drug's evidence against variants, including data from the Washington University School of Medicine showing that Evusheld protects against the BA.2 subvariant, the highly transmissible globally dominant strain. A new preclinical study from the University of Oxford showed that the drug also neutralizes against the emerging Omicron BA.4 and BA.5 variants.
The variant protection is highly sought out in the COVID-19 antiviral market. The U.S. has already paused the distribution of GlaxoSmithKline and Vir Biotechnology’s antibody drug sotrovimab in the northeast due to the omicron BA.2 subvariant.
The FDA also halted Regeneron’s REGEN-COV and Eli Lilly’s antibody cocktail, with the agency saying the treatments are “highly unlikely” to be active against the omicron variant.
Pfizer’s oral antiviral, Paxlovid, while not in high demand, is seeing increased availability in the U.S., with the government ordering 20 million courses. The drug proved that it reduced COVID-19 deaths or hospitalizations by 90% in a clinical trial.