The first long-acting preventive new crown antibody combination drug Phase 3 has a positive clinical effect and significantly reduces the incidence of symptoms

August 21, 2021, Shanghai, China - AstraZeneca's AZD7442 PROVENT Phase III pre-exposure prevention clinical trial has achieved positive results, significantly reducing the incidence of symptomatic new coronary pneumonia ( COVID-19 ) and reaching the primary endpoint

As a combination of two long-acting antibodies (LAAB), AZD7442 can reduce the incidence of symptomatic new coronary pneumonia by 77% (95% confidence interval (CI): 46, 90) compared to the control group

Among the subjects treated with AZD7442, there were no severe cases or deaths caused by infection with the new coronavirus

AZD7442 is the first optimized antibody combination drug (non-vaccine) that has been proven to be capable of long-term prevention of new coronary pneumonia in clinical trials

A total of 5197 subjects were enrolled in this clinical trial, of which the AZD7442 test group and the control group were randomly allocated according to the number of cases 2:1.

Preliminary data analysis showed that subjects tolerated AZD7442 well, and the incidence of adverse events was the same in the control group and the AZD7442 test group

Myron J.

Mene Pangalos , executive vice president of AstraZeneca and head of biopharmaceutical research and development, said: "We hope to find other ways for people who have not yet been fully protected by the new crown vaccine

AZD7442 is optimized by AstraZeneca’s proprietary YTE half-life extension technology.

The results of in vitro experiments conducted by researchers at Oxford University in the United Kingdom and Columbia University in the United States showed that AZD7442 can neutralize the newly discovered SARS-CoV-2 mutant virus, including the delta mutant strain

AstraZeneca will submit these preventive studies (PROVENT and STORM CHASER) data to regulatory agencies, seeking emergency use authorization or conditional approval

About PROVENT

PROVENT is a randomized, double-blind, placebo-controlled, multi-center phase III clinical trial designed to evaluate the safety and effectiveness of a single dose of AZD7442 300 mg in the prevention of new coronaviruses

The primary efficacy endpoint of PROVENT was the first positive case of SARS-CoV-2 RT-PCR within 183 days after receiving the injection

All subjects are adults 18 years of age and older, and are high-risk groups that are expected to benefit from the preventive mechanism of the long-acting antibody combination drug: insufficient immune response (weak vaccine response or vaccine intolerance) or more likely to be infected with SARS- The CoV-2 virus may be exposed to the high-risk environment of SARS-CoV-2 virus infection

Approximately 43% of the subjects are people 60 years and older, and more than 75% are accompanied by underlying diseases and other diseases (including immunosuppressive diseases or taking immunosuppressive drugs, diabetes , severe obesity or heart disease, chronic obstructive pulmonary disease, chronic Kidney and liver diseases), once infected with the new coronavirus, the risk of developing severe illness is higher

About AZD7442

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

A comprehensive clinical trial involving more than 9,000 people is underway to evaluate the role of AZD7442 in the prevention and treatment of new coronaviruses, including TACKLE COVID-1913, a phase III clinical trial conducted in an outpatient clinic, and a combination of outpatient treatment and inpatient treatment Research
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In addition, the evaluation of the different modes of administration of AZD7442 intramuscularly and intravenously is also underway
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