The trial, called NCT04507256, will evaluate the safety, tolerability and pharmacokinetics of AZD7442.
The trial will include up to 48 healthy participants in the UK aged 18 to 55 years and is funded by the Defense Advanced Research Projects Agency (DARPA), part of the US Department of Defense, 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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19.
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.”
Should AZD7442 prove to be tolerated and have a favourable safety profile in the trial, AstraZeneca will 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. The treatment has the potential to be given as a preventative option for people exposed to the virus, and to treat and prevent disease progression in patients already infected by the virus.
AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection.
Discovered by Vanderbilt University Medical Center 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.
In a recent Nature publication, the 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.
NCT04507256 is a Phase I, 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.
Data readout is anticipated in the second half of 2020.”