Long-Acting Antibody AZD7442 Offers New Hope for Individuals with Suboptimal Response to COVID-19 Vaccines

Today, AstraZeneca announced the latest results of its long-acting COVID-19 neutralizing antibody AZD7442 in two Phase III clinical trials for the prevention and treatment of COVID-19. The trial results showed that a single intramuscular injection of AZD7442 reduced the risk of developing symptomatic COVID-19 by 83% over a six-month follow-up period.

The press release pointed out that 2% of the world's population may respond poorly to the COVID-19 vaccine for various reasons (such as blood cancer patients undergoing chemotherapy, patients on dialysis, and those with multiple sclerosis or rheumatoid arthritis taking immunosuppressive drugs, etc.). This result shows that long-acting neutralizing antibodies could provide them with long-term protection and offer a new option for controlling the pandemic.

AZD7442 is a long-acting neutralizing antibody combination therapy jointly developed by AstraZeneca and Vanderbilt University Medical Center. It consists of two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. AstraZeneca optimized the antibodies, extending their half-life to three times that of conventional monoclonal antibodies, with the aim of providing up to 12 months of protection after a single injection. AstraZeneca has submitted an application to the U.S. FDA seeking emergency use authorization for AZD7442 to prevent or treat COVID-19.

This randomized, double-blind, placebo-controlled Phase 3 clinical trial focused on recruiting high-risk and immunocompromised volunteers, with over 75% of participants having comorbidities at baseline, including populations who may experience reduced vaccine immune responses due to immunocompromisation.

At a median follow-up time of 6 months, a single dose of AZD7442 reduced the risk of volunteers developing symptomatic COVID-19 by 83% compared to placebo. Additionally, no severe cases or deaths occurred in the AZD7442 group, while there were 5 severe cases and 2 COVID-19-related deaths in the control group.

In addition, in another Phase III clinical trial for the treatment of patients with mild to moderate COVID-19, AZD7442 reduced the risk of severe disease or death by 88% when administered within three days of symptom onset.

Professor Hugh Montgomery of University College London, the chief investigator of AZD7442, said: "These results give us confidence that the long-acting antibody combination therapy can provide long-term protection for vulnerable populations, helping them return to normal life."

Currently, neutralizing antibody therapies from multiple biopharmaceutical companies have received approvals or emergency use authorizations from regulatory agencies around the world. They cannot replace COVID-19 vaccines but, together with COVID-19 vaccines, small-molecule antiviral drugs, and other COVID-19 treatment methods, provide people with a more diverse range of tools to combat the pandemic.

References:

[1] New analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention. Retrieved November 18, 2021, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html

[2] BIO COVID-19 Therapeutic Development Tracker. Retrieved November 14, 2021, from https://www.bio.org/policy/human-health/vaccines-biodefense/coronavirus/pipeline-tracker

▽Follow 【WuXi AppTec】Germany】WeChat Official Account