AstraZeneca doses first patients in COVID-19 therapy trial
The Phase I trial will assess the safety and pharmacokinetics of the AZD7442 monoclonal antibody combination in 48 healthy participants.
The first patients have been dosed in AstraZeneca’s Phase I trial assessing the safety, tolerability and pharmacokinetics of the company’s AZD7442 monoclonal antibody (mAb) combination. AZD7442 is being developed for prevention and treatment of COVID-19.
The trial, called NCT04507256, will enrol up to 48 healthy participants in the UK aged between 18 and 55 years. It is a is a Phase I, first-in-human (FIH), randomised, double-blind, placebo-controlled, dose escalation study. Data is expected from the trial in the second half of 2020.
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, the enterprise will progress it into larger late-stage trials to evaluate its efficacy as a potential preventative and treatment approach against COVID-19.
AZD7442 is a combination of two mAbs derived from convalescent COVID-19 patients. AstraZeneca has optimised the mAbs since their initial discovery at Vanderbilt University Medical Center, US, by extending their half-life and reducing Fc receptor binding. It is hoped the half-life extension will afford patients with at least six months of protection from COVID-19.
In preclinical research published in Nature, the mAbs were shown to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.