AstraZeneca PLC - Ph I trial begins for COVID-19 monoclonal antibody
Phase I clinical trial initiated for monoclonal antibody combination
for the prevention and treatment of COVID-19
First participants dosed in trial of AZD7442 to assess safety,
tolerability and pharmacokinetics of the combination
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
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 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection. Discovered by
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.
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
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
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the
Quick facts: AstraZeneca
Market Cap: £106.51 billion
NO INVESTMENT ADVICE
The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...FOR OUR FULL DISCLAIMER CLICK HERE