AstraZeneca Seeks EUA for Long-Acting Antibody Combination for COVID-19 Prevention

TURIN, ITALY – FEBRUARY 28: Blood and plasma samples used for the evaluation swabs for Coronavirus in the research laboratory of the Amedeo di Savoia hospital in Turin during of the Northern Italy In The Grip Of Covid-19 Coronavirus on February 28, 2020 in Turin, Italy. (Photo by Stefano Guidi/Getty Images)
The submission is supported by data from the phase 3 PROVENT and STORM CHASER trials.

AstraZeneca is seeking Emergency Use Authorization (EUA) for AZD7442, a combination of 2 long-acting monoclonal antibodies for prophylaxis of symptomatic COVID-19.

The investigational antibodies, tixagevimab and cilgavimab, are designed to bind to distinct sites on the SARS-CoV-2 spike protein. According to the Company, the antibody therapy has been optimized with half-life extension that could afford up to 12 months of protection from COVID-19 with a single administration. 

The submission is supported by data from the phase 3 PROVENT (ClinicalTrials.gov Identifier: NCT04625725) and STORM CHASER (ClinicalTrials.gov Identifier:  NCT04625972) trials, which compared the efficacy and safety of AZD7442 to placebo for pre-exposure and post-exposure prophylaxis, respectively, of COVID-19 in participants 18 years of age and older. Participants were randomly assigned 2:1 to receive a single intramuscular dose of either 300mg of AZD7442 or saline placebo, administered as 2 separate intramuscular injections. 

The primary endpoint for both trials was incidence of the first case of SARS-CoV-2 reverse transcriptase-polymerase chain reaction positive symptomatic illness occurring post dose prior to day 183. 

Findings from the PROVENT trial (N=5172) showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% CI, 46-90) compared with placebo. There were no cases of severe COVID-19 or COVID-19-related deaths in the AZD7442 treatment arm compared with 3 cases of severe COVID-19 in the placebo arm, including 2 deaths. 

Findings from the STORM CHASER trial (N=1121) showed that in the overall trial population (primary analysis), AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% (95% CI, -26, 65) compared with placebo, which was not statistically significant. In a pre-planned subgroup analysis, AZD7442 reduced the risk of developing symptomatic COVID-19 by 73% (95% CI, 27-90) vs placebo, in participants who were PCR negative at the time of dosing. A post-hoc analysis showed that in PCR-negative participants, AZD7442 was associated with a 92% (95% CI, 32-99) reduction in risk more than 7 days following dosing, and a 51% (95% CI, -71, 86) reduction in risk up to 7 days following dosing.

“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year.”

References

  1. AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US. News release. AstraZeneca. Accessed October 5, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-request-for-emergency-use-authorization-for-covid-19-prophylaxis-filed-in-us.html
  2. Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19. News release. AstraZeneca. June 15, 2021. Accessed October 5, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/update-on-azd7442-storm-chaser-trial.html.

This article originally appeared on MPR