Phase I clinical trial initiated for monoclonal antibody combination for the prevention and treatment of COVID-19

AstraZenecaThe 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.

About 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)

About 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.

About AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) 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.

1. ClinicalTrials.gov. NCT04507256. https://clinicaltrials.gov/ct2/show/NCT04507256?term=NCT04507256&draw=2&rank=1 2. Robbie, G.J., et al., A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother, 2013. 57(12): p. 6147-53. 3. Griffin, M.P., et al., Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(3). 4. Yu, X.Q., et al., Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(1). 5. Domachowske, J.B., et al., Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J, 2018. 37(9): p. 886-892. 6. Zost SJ et al. Potently neutralizing human antibodies that block SARS-CoV-2 receptor binding and protect animals. Nature. 2020. DOI: 10.1038/s41586-020-2548-6

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