The results showed that one 300 mg dose of AZD7442 reduced the risk of developing symptomatic COVID-19 by 83% and one 600 mg dose reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to the placebo.
Results from the Phase 3 trials AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment showed robust efficacy from a 1-time intramuscular dose of the long-acting antibody combination, according to a press release.
“AZD7442 is the only long-acting antibody with Phase 3 data to demonstrate benefit in both pre-exposure prophylaxis and treatment of COVID-19 with 1 dose. These new data add to the growing body of evidence supporting AZD7442’s potential to make a significant difference in the prevention and treatment of COVID-19,” Mene Pangalos, executive vice president for BioPharmacuticals R&D of AstraZeneca, said in a statement.
In the analysis of the ongoing PROVENT trial evaluating a median 6 months of participant follow up, one 300 mg dose of AZD7442 reduced the risk of developing symptomatic COVID-19 by 83% when compared to the placebo.
The PROVENT trial is the first phase 3 trial prospectively designed of evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19 with targeted inclusion of those who are high-risk and immunocompromised. More than 75% of individuals at baseline had comorbidities that put them at high risk for severe COVID-19, if infected, according to the press release.
There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442 at either primary or 6-month analyses. There were a total of 5 severe COVID-19 cases and 2 COVID-19-related deaths for those treated with the placebo.
In the TACKLE outpatient treatment trial for individuals with mild to moderate COVID-19, the results showed that one 600 mg dose of AZD7442 reduced the risk of developing severe COVID-19 or death from any cause by 88% compared to the placebo for individuals who had been symptomatic for 3 days or less at the time of treatment, according to the study authors.
A total of 80% of individuals were from population at high risk of progression to severe COVOD-19 if they become infected, including those with comorbidities.
“These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives. Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination,” Hugh Montgomery, professor of intensive care medicine at the University College of London, said in a statement.
In both trials, AZD7442 was generally well tolerated, and no new safety issues were identified in the 6-month analysis of PROVENT.
Full results for both trials were submitted for a publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting, according to the press release.
AstraZeneca has agreed to supply the United States government with 700,000 doses if granted an Emergency Use Authorization by the FDA and has agreed to supply other countries.
New Analyses of Two AZD7442 COVID-19 Phase III Trials in High-Risk Populations Confirm Robust Efficacy and Long-Term Prevention. Business Wire. News release. November 18, 2021. Accessed November 22, 2021. https://www.businesswire.com/news/home/20211118005506/en