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NIH trial of AZ's long-acting COVID-19 antibody launches in the US

Study will evaluate efficacy of drug in patients hospitalised with COVID-19

A US government-funded trial of AstraZeneca’s (AZ) long-acting antibody (LAAB) therapy AZD7442 has launched to evaluate the efficacy of the drug in patients hospitalised with COVID-19.

The ACTIV-3 study is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH).

The study will evaluate the safety and efficacy of the investigational LAAB combination for the treatment of individuals hospitalised with COVID-19.

AZD7442 is based on antibodies isolated from two patients who had recovered from COVID-19 by researchers at the Vanderbilt University Medical Center in the US.

The LAAB combination was designed using AZ’s half-life extension technology, with the aim of helping the therapy to work for a longer period of time.

The first patients in the ACTIV-3 sub-study of AZD7442 will be patients hospitalised with mild-to-moderate COVID-19 who have had symptoms for less than 13 days.

Approximately 150 participants will be assessed after five days of receiving the drug, at which point enrolment into the AZD7442 study could be expanded, depending on the success of the drug in the early stage.

An additional 700 participants, that could include patients with more severe cases of COVID-19, will then be enrolled and randomised in the trial

AZ has received around $486m in support from the US government for the development and supply of AZD7443, as part of an agreement with the Biomedical Advanced Research and Development Authority (BARDA).

Under the terms of a separate agreement, the US government can acquire up to one million doses of AZD7442 in 2021.

“This agreement with the US government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections,” said Pascal Soriot, chief executive officer of AZ.

“We will be evaluating the LAAB combination in different settings from prophylaxis, to outpatient treatment to hospitalisation, with a focus on helping the most vulnerable people,” he added.

AZD7442 is also being studied to prevent COVID-19 infection for up to 12 months in approximately 5,000 participants.

A second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in around 1,100 participants.

Article by
Lucy Parsons

10th February 2021

From: Research

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