(Alliance News) - Anglo-Swedish drugmaker AstraZeneca PLC on Tuesday said the first patients have now been dosed in its phase one trial of Covid-19 treatment, AZD7442.
The trial, named NCT04507256, will evaluate AZD7442's safety, tolerability, and pharmacokinetics. Pharmacokinetics describes the movement of a treatment into the body, as well as through and out of the body.
AZD7442 is a combination of two monoclonal antibodies and is being developed for the development and treatment of Covid-19. These antibodies are derived from convalescent patients infected with SARS-CoV-2 and were discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June.
Astra then optimised the antibodies, extending their half-life so as to "afford at least six months of protection from Covid-19".
If AZD7442 proves to be tolerated and has a "favourable safety profile" in the NCT04507256 trial then Astra will move to larger late-stage phase 2 and phase 3 trials. These later trials will evaluate AZD7442's efficacy as a possible preventative and treatment approach against the virus.
The trial will include as many as 48 healthy participants in the UK aged between 18 and 55. It is funded by the Defense Advanced Research Projects Agency, part of the US US Department of Defense, as well as the Biomedical Advanced Research and Development Authority. BARDA is part of the Office of the Assistant Secretary for Preparedness & Response at the US Department of Health & Human Services.
Mene Pangalos, executive vice president of BioPharmaceuticals Research & Development, 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."
Alongside the antibody treatment, Astra is also developing a vaccine for Covid-19 with the University of Oxford. This vaccine would aim to prevent Covid-19 infection. In July, interim results from an ongoing phase 1/2 trial of vaccine AZD1222 were published showing it to be tolerated and able to generate robust immune responses against the virus in all evaluated participants. Phase 2/3 trials are ongoing with late-stage trial results expected later in 2020.
On Monday, the UK Government said it struck a deal with AstraZeneca to get "first access" to a vaccine once approved.
By Anna Farley; annafarley@alliancenews.com
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Astrazeneca (AZN)