AstraZeneca’s COVID-19 Antibody 77% Effective in Phase 3 Trial
Researchers reported no cases of severe coronavirus or coronavirus-related death in patients treated with the COVID-19 antibody combination, AZD7442.
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By - AstraZeneca recently announced that its COVID-19 antibody combination, AZD442, reduced the risk of symptomatic coronavirus by 77 percent compared to placebo in a Phase 3 trial.
The randomized, double-blind PROVENT clinical trial enrolled 5,197 participants to receive AZD7442 300 milligrams or placebo. Researchers conducted the trial in 87 sites in the US, UK, Spain, France, and Belgium.
The primary analysis consisted of 25 cases of symptomatic COVID-19 and 5,172 participants who were not infected. The primary endpoint of the trial was the first case of any COVID-19 RT-PCR positive symptomatic illness occurring post-dose prior to day 183.
Overall, there were no cases of severe COVID-19 or COVID-19-related death in those treated with AZD7442, researchers explained. But there were three cases of severe COVID-19 in the placebo arm and two deaths.
Researchers will follow participants for 15 months.
"The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19. AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives,” Myron J. Levin, MD, professor of pediatrics and medicine at the University of Colorado School of Medicine and principal investigator of the trial, said in the announcement.
AZD7442 is a combination of two long-acting antibodies (LAABs), tixagevimab and cilgavimab. Vanderbilt University derived the antibody combination from convalescent patients who donated B-cells after COVID-19 infection. The university licensed the antibody combination to AstraZeneca in June 2020.
If FDA authorizes the use of AZD7442, the government will distribute the doses at no cost. But healthcare professionals could still charge for the cost of administering the product.
AstraZeneca optimized AZD7442 using its proprietary YTE half-life extension technology. Currently, researchers are studying AZD7442 in a clinical trial program for both prevention and treatment of COVID-19 in over 9,000 participants.
One of the trials, TACKLE COVID-19, is a Phase 3 treatment trial in outpatient and hospitalized settings. Researchers will test the antibody for both IM and intravenous administration routes.
Notably, AZD7442 is the first antibody combination modified to provide long-lasting protection that has demonstrated the prevention of COVID-19 in a clinical trial.
“We need additional approaches for individuals who are not adequately protected by COVID-19 vaccines. We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines,” said Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca.
AstraZeneca stated that it will share further data from the AZD7442 Phase 3 clinical trial program later this year.
