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AZ’s long-acting COVID-19 antibody fails to meet primary endpoint in prevention trial

AZD7442 is based on antibodies isolated from two patients who had recovered from COVID-19

AstraZeneca’s long-acting COVID-19 antibody AZD7442 failed to hit the primary endpoint in a phase 3 prevention trial, the drugmaker announced today. 

The STORM CHASER trial is a randomised placebo-controlled trial designed to evaluate the safety and efficacy of a single 300mg dose of AZD7442 for the post-exposure prevention of COVID-19.

The trial, conducted in sites across the UK and US, randomised 1,121 participants in a 2:1 ratio to receive a single intramuscular dose of either AZD7442 or two doses of saline placebo.

The participants were unvaccinated adults aged 18 years and older with confirmed exposure to a person with a positive COVID-19 case within the past eight days.

All participants had a negative SARS-CoV-2 antibody test on the day of dosing to ensure there was no prior infection, and a nasopharyngeal swab was also collected and tested for SARS-CoV-2 using RT-PCR analysis.

In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% compared to placebo, although this was not a statistically significant finding.

However, a pre-planned analysis of SARS-CoV-2 PCR positive and PCR negative participants showed that, in patients who were PCR negative at the time of dosing, AZD7442 reduced the risk of developing symptomatic COVID-19 by 73% compared with placebo.

A post-hoc analysis also showed that, in participants who were PCR negative at baseline, AZD7442 reduced the risk of developing symptomatic COVID-19 by 92% versus placebo for more than seven days following dosing and by 51% up to seven days following doses.

“While this trial did not meet the primary endpoint against symptomatic illness, we are encouraged by the protection seen in the PCR negative participants following treatment with AZD7442,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ.

“We await results from PROVENT, our pre-exposure prevention trial and TACKLE, our treatment trial in preventing more severe disease, to understand the potential role of AZD7442 in protecting against COVID-19,” he added.

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.

Article by
Lucy Parsons

15th June 2021

From: Research

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