November 29, 2021

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AstraZeneca COVID-19 therapy AZD7442 achieved positive results in trials

https://www.astrazeneca.com/

AstraZeneca COVID-19 therapy AZD7442 achieved positive results in trials



 

AstraZeneca COVID-19 therapy AZD7442 achieved positive results in trials.

Reduce the risk of COVID-19 infection by 83%: AstraZeneca‘s long-acting COVID-19 neutralizing antibody has achieved positive results in two Phase III clinical trials.


On November 19, AstraZeneca announced that its COVID-19 long-acting antibody combination therapy AZD7442 has shown excellent efficacy in the high-risk prevention phase III clinical PROVENT study and the phase III clinical TACKLE study for outpatients.

 

The 6-month follow-up data of the prevention trial showed that the one-time intramuscular injection of the long-acting antibody combination reduced the risk of symptomatic COVID-19 by 83%; a separate treatment trial showed that if you receive treatment within three days after the symptoms appear, you will suffer from severe COVID-19 -19 or the risk of death can be reduced by 88%.

 

AstraZeneca COVID-19 therapy AZD7442 achieved positive results in trials AstraZeneca COVID-19 therapy AZD7442 achieved positive results in trials

 

Approximately 2% of the global population is at high risk of insufficient response to the COVID-19 vaccine, including cancer patients undergoing chemotherapy, dialysis patients, patients taking drugs after organ transplantation, or immunosuppressive drugs for multiple sclerosis and similar diseases. Patients with diseases such as rheumatoid arthritis.

 

PROVENT is a phase III, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the pre-exposure prevention of AZD7442 for symptomatic COVID-19.

The study included high-risk and immunocompromised subjects, and more than 75% of the subjects had comorbidities, which meant that they would face a higher risk of severe illness when they were infected.

5197 subjects randomly received 300 mg AZD7442 (n = 3,460) or placebo (n = 1,737) at a 2:1 ratio.

 

No matter in the first analysis or the six-month follow-up, there were no severe or COVID-19-related deaths in the AZD7442 treatment group; while in the placebo group, there were 5 severe COVID-19 cases and 2 COVID-19-related deaths. die.

 

TACKLE is a phase III, randomized, double-blind, placebo-controlled, multicenter trial involving 903 patients and evaluating the efficacy of a single 600 mg intramuscular injection of AZD7442 compared with placebo for the outpatient treatment of mild and moderate COVID-19 Safety and effectiveness.

 

Exploratory analysis showed that compared with placebo, AZD7442 600 mg IM reduced the risk of severe COVID-19 or death by 88% in patients within 3 days of onset of symptoms.

 

In terms of safety, AZD7442 was well tolerated in two phase III clinical trials, and no new safety issues were found in the six-month follow-up analysis.

 

Mene Pangalos, Executive Vice President of Research and Development of AstraZeneca, said: “AZD7442 is the only long-acting antibody with phase III data, and benefits both in pre-exposure prevention and single-dose treatment of COVID-19.

New evidence supports the role of AZD7442 in COVID-19. Prevention and treatment are expected to have a significant impact. We are advancing regulatory filings globally and look forward to providing new treatment options for the COVID-19 as soon as possible.”

 

On October 5, 2021, AstraZeneca announced that it had submitted an emergency use authorization request (EUA) for AZD7442 to the US FDA to prevent COVID-19.

After approval, AstraZeneca will supply 700,000 doses of AZD7442 to the US government and has agreed to supply it to other countries.

 

AZD7442 is a combination of two long-acting antibodies tixagevimab (AZD8895) and cilgavimab (AZD1061), extracted from B cells of convalescent patients infected with SARS-CoV-2 virus.

It was discovered by Vanderbilt University Medical Center, and authorized to AstraZeneca in June 2020.

AstraZeneca uses its proprietary YTE half-life extension technology to optimize neutralizing antibodies to reduce the binding of Fc receptors and complement C1q, so that a single intramuscular injection can provide up to 12 months of preventive immune protection, which is better than general anti- More than three times the body length.

 

 

 

 

 

AstraZeneca COVID-19 therapy AZD7442 achieved positive results in trials

(source:internet, reference only)


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