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expert reaction to press release from AstraZeneca announcing new analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention

The press release from AstraZeneca suggests six-month follow-up of their prevention trial showed 83% reduced risk of symptomatic COVID-19 and no severe disease or deaths with their long-acting antibody (LAAB) combination, AZD7442.

 

Dr Dipender Gill, NIHR Clinical Lecturer in Clinical Pharmacology and Therapeutics at St George’s, University of London, said:

“This is an important development that adds to the armamentarium against covid-19, specifically for prevention and early treatment. The key question now is how the various monoclonal antibody therapies for covid-19 should be clinically implemented. Furthermore, the role of monoclonal antibodies once oral SARS-CoV-2 antiviral agents become available is also not clear, particular as their therapeutic window and target populations are likely to overlap, and that antivirals can be taken from home.”

 

Prof Penny Ward, Independent Pharmaceutical Physician, Visiting Professor in Pharmaceutical Medicine at Kings College, London, said:

“The press release today provides an update on the efficacy of the long acting monoclonal antibody combination AZD7442 for the primary prevention of COVID-19; in the first report from this trial a single IM injection of 300mg AZD7442 reduced the incidence of symptomatic COVID occurring within 183 days by over 77% compared to placebo. The new analysis has demonstrated an improvement in this with protection rising to 83% following a longer period of investigation. There were no serious cases or deaths among the AZD7442 recipients.

“The company has also investigated a higher dose – 600mg- given within 7 days of symptoms to patients with mild-moderate COVID, demonstrating a 50% reduction in incidence of hospitalisation/death within 29 days compared to placebo. This new analysis reports that earlier intervention – within 3 days of first symptom onset- deduced the incidence of hospitalisation/death by 88%.

“Regrettably neither study has been published in full and thus our ability to assess these data is limited. AZD are encouraged to publish the complete trial data and detailed results as rapidly as possible to enable prescribers to understand how best to use the product in practice.

“This antibody cocktail is, uniquely, capable of offering long lasting protection from COVID to patients that are immunosuppressed and may not have responded effectively to vaccination. If may yet come to be considered an important adjunctive treatment for cancer patients and others needing immunesuppressing therapy for other diseases.

“As its effect is long lasting – one treatment may offer protection for as long as a year, it is arguably preferable to other short acting MAb combinations that require repeat doses to be effective in preventing illness. As a treatment, its efficacy appears, if given early enough following first onset of illness, to be on a par with the recent results from trials with oral antivirals and the IM route of administration permits administration within the community, in contrast to other MAb cocktails which require IV administration.

“I look forward to seeing the detailed data but if this confirms the information in the press release, this is an important addition to the therapeutic armamentarium for COVID. Let us hope a good supply of this product has been secured for use in the UK.”

 

 

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html

 

 

Declared interests

Dr Dipender Gill: “I am employed part-time by Novo Nordisk, unrelated to the current topic.”

Dr Penny Ward: “No COIs. I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody). These are my personal views and do not reflect those of either institution.”

 

 

 

 

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