AstraZeneca reports that its antibody combination, AZD7442, has shown strong effects in the prevention and treatment of COVID-19 With an intramuscular dose.
What is this
AZD7442 is a combination of two long-acting antibodies (LAABs). AstraZeneca has also developed a major COVID-19 vaccine in collaboration with the University of Oxford. India’s Covishield is a version of the Oxford-AstraZeneca vaccine.
AstraZeneca based in the UK was licensed coronavirusIn June 2020 neutralizing antibodies from Vanderbilt University, US, and a pair of these monoclonal antibodies were advanced into clinical development. AZD7442 is a combination of LAABs called ‘tixagevimab’ and ‘cilgavimab’, discovered by Vanderbilt University Medical Center; these human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein. AstraZeneca said they were adapted by AstraZeneca’s technology, which more than tripled the durability of its action compared to conventional antibodies.
The findings come from the AZD7442 COVID-19 PROVENT PREVENTION and TACKLE OUTPATIENT TREATMENT Phase 3 trials. The PROVENT trial is assessing a single IM 300mg dose of AZD7442 compared to placebo in participants who did not have SARS-CoV-2 infection at baseline. The 600mg IM dosage is being assessed for outpatient treatment of COVID-19 in the Tackle trial. AstraZeneca said the trial demonstrated benefits in both pre-exposure prophylaxis and treatment of COVID-19.
PROVENT was held at 5,197 participants across 87 sites in the US, UK, Spain, France and Belgium. A single 300mg IM dose of AZD7442 was found to reduce the risk of developing symptomatic COVID-19 by 83% compared to placebo. More than 75% of PROVENT participants at baseline had a comorbidity that put them at high risk. After six months, there were no cases of severe COVID or COVID-related deaths among those treated with AZD7442. In the placebo arm, there were a total of five severe COVID cases and two COVID-related deaths.
In TACKLE, it was performed on 903 participants – outpatients with mild to moderate covid. A single 600mg IM dose was found to reduce the risk of developing severe COVID-19 or death (from any cause) by 88% compared to a placebo. A total of 90% of the participants were from a population at high risk of progressing to severe COVID when infected.
In both trials, AZD7442 was generally well tolerated, AstraZeneca said.
why it matters
In a virtual press meet announcing the findings, experts said that around 2% of the global population is believed to be at increased risk of an inadequate response to a COVID vaccine. These include people with blood cancer or other cancers who are being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant, or those who are taking immunosuppressant drugs for conditions including multiple sclerosis and rheumatoid arthritis.
PROVENT is the first phase 3 trial designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of potentially symptomatic COVID, including targeting high-risk and immunocompromised participants, he said.