AstraZeneca begins phase 1 trial of Covid-19 dual-use candidate AZD7442

AstraZeneca has initiated a phase 1 trial of a monoclonal antibody combination called AZD7442, which is being developed for the prevention and treatment of Covid-19.

Dubbed as NCT04507256, the early-stage trial will assess the safety, tolerability, and pharmacokinetics of AZD7442, which is a combination of two monoclonal antibodies (mAbs).

The NCT04507256 trial will feature up to 48 healthy participants in the UK, aged between 18 and 55 years. AstraZeneca said that it has dosed the first participants with the monoclonal antibody combination.

The early-stage trial of the monoclonal antibody combination is funded by the US Defense Advanced Research Projects Agency (DARPA) and the US Biomedical Advanced Research and Development Authority (BARDA).

It will be a randomised, double-blind, placebo-controlled, and dose escalation study whose results are expected to come out in the second half of 2020.

AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos 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.”

AstraZeneca said that if AZD7442 is found to be tolerated and is shown to have a favourable safety profile in the NCT04507256 trial, then it will be advanced into larger phase 2 and 3 trials. In the latter stage trials, the monoclonal antibody combination will be assessed for its efficacy as an investigational preventative and treatment approach against the novel coronavirus.

As per AstraZeneca, monoclonal antibodies which are synthesised in the laboratory aim to mimic natural antibodies. The pharma major said that monoclonal antibodies have the potential to be given as a preventative option for those exposed to the virus, and also for treatment and prevention of disease progression in those who are already infected by the virus.

AZD7442 is said to have been prepared by combining two monoclonal antibodies extracted from convalescent patients with SARS-CoV-2 infection. The monoclonal antibody combination was discovered by US-based Vanderbilt University Medical Center and was licensed to AstraZeneca in June 2020.

The pharma major is said to have optimised the mAbs with half-life extension and reduced Fc receptor binding.

AstraZeneca is also engaged in bringing a vaccine called AZD1222 for Covid-19 to the global markets in partnership with the UK-based Oxford University.