# AstraZeneca Phase I clinical trial initiated for COVID-19 monoclonal antibody

- Link: https://www.directorstalkinterviews.com/astrazeneca-phase-i-clinical-trial-initiated-for-covid-19-monoclonal-antibody/412854496
- Published: 2020-08-25T07:17:11+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
has confirmed that the first participants have been dosed in a Phase I trial of 
AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the
prevention and treatment of COVID-19.

The trial, called NCT04507256, will evaluate the safety, tolerability and pharmacokinetics
of AZD7442.^(1) 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**

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.^(2-5) 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.^(
6)

**NCT04507256**

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.^(1) Data readout is anticipated
in the second half of 2020.

**As****traZeneca**

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the
discovery, development and commercialisation of prescription medicines, primarily
for the treatment of diseases in three therapy areas – Oncology, Cardiovascular,
Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca
operates in over 100 countries and its innovative medicines are used by millions
of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter@
AstraZeneca.

Share on: