The drug known as AZD7442 has the potential to be given as a preventative option for people exposed to the coronavirus and to treat and prevent disease progression in patients already infected by the deadly virus. The Cambridge-based British-Swedish multinational AstraZeneca, which is also working with the University of Oxford on a vaccine to combat the coronavirus, said the drug is a combination of two monoclonal antibodies (mAbs) and the first participants have been dosed with it for the Phase I trial.
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This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19, said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, at AstraZeneca. This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance, said Pangalos.
The trial, named NCT04507256, will evaluate the safety, tolerability and pharmacokinetics, or drug movement through the human body, of AZD7442. It will include up to 48 healthy participants in the UK, aged 18 to 55 years.
Should AZD7442 prove to be tolerated and have a favourable safety profile in the trial, the firm says it will then progress it into larger late-stage Phase II and Phase III trials to evaluate its efficacy as a potential preventative and treatment approach against COVID-19. Synthesised in the laboratory, mAbs aim to mimic natural antibodies.
AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2, or COVID-19, infection.
Discovered by Vanderbilt University Medical Centre and licensed to AstraZeneca in June 2020, the mAbs were optimised by AstraZeneca with half-life extension and reduced Fc receptor binding.
The half-life extended mAbs should afford at least six months of protection from COVID-19, notes AstraZeneca. The firm cites a recent publication in Nature', where mAbs were shown preclinically to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.
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The NCT04507256 Phase I trial is the first time in human, randomised, double-blind, placebo-controlled, and dose-escalation study that aims to evaluate the safety, tolerability and pharmacokinetics of AZD7442 in healthy participants. The data readout from the study is anticipated later this year.
The company said the trial is funded by the Defence Advanced Research Projects Agency (DARPA), part of the US Department of Defence, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.