Vaccines are still on the front line to prevent Covid-19, but an experimental drug from AstraZeneca is being released clinical information Show that it can provide additional measures. The pharmaceutical giant has now obtained the results of a key Phase 3 study showing that its antibody drug successfully reduced Covid infections by 77%.
With these results, AstraZeneca said on Friday that it will prepare the emergency authorization or conditional approval of the drug AZD7442 submitted by the regulatory agency to prevent Covid-19.
Vaccines encourage the immune system to produce antibodies to prevent infection. Preventive antibody drugs are designed to provide patients with antibodies that their body does not produce from vaccination.Has developed antibody drugs for the treatment of Covid-19 infection, including drugs authorized by the FDA Regeneron Pharmaceutical, Eli Lilly, with For biotechnologyAstraZeneca is also developing AZD7442 as a treatment for Covid-19. But Friday’s clinical trial results report that the drug is supported to help patients who need drugs other than vaccines to help prevent infection in the first place.
The Phase 3 placebo-controlled study called PROVENT recruited 5,197 adults in 97 locations in the United States, United Kingdom, Spain, France, and Belgium. These participants were adults, and they were predicted to respond poorly to the vaccine or intolerant to them. The study also included people whose conditions put them at a higher risk of exposure to the virus. According to the company, more than 75% of study participants have underlying diseases associated with reduced immune responses to vaccination. The main goal of the clinical trial is to measure Covid-19 infection cases, which was confirmed by PCR testing and occurred after the administration until the 183th day of the study.
AstraZeneca stated that the trial produced 25 symptomatic Covid-19 cases at the main analysis point. Among patients treated with AZD7442, no serious illnesses or Covid-related deaths were reported. In the placebo-administered group, 3 severe Covid-19 cases were reported, including 2 deaths. Patients tolerated the AstraZeneca antibody combination well, and the company said that preliminary analysis showed a balance of adverse events between the placebo group and the treatment group. Participants in the study will continue to be followed for 15 months.
AZD7442 is a combination of two long-acting antibodies, tixagevimab and cilgavimab. Both antibodies are derived from B cells donated by SARS-CoV-2 convalescent patients.AstraZeneca Licensed The antibody was discovered last year from Vanderbilt University Medical Center. These antibodies bind to different sites of the new coronavirus. This method is designed to improve efficacy and reduce the chance of viral mutations that make the drug ineffective.
Although antibody drugs currently available for Covid-19 treatment are also being developed to prevent SARS-COV-2 infection, AstraZeneca’s drugs can provide two advantages.Unlike the currently authorized intravenous infusion of antibody drugs, AZD7442 is a more patient-friendly intramuscular injection (although Vir and Regeneron is also developing an injectable version of the antibody drug). AstraZeneca also designed AZD7442 to provide longer-term protection. AstraZeneca applied a proprietary technology to Vanderbilt antibodies to extend their half-life to last up to 12 months. In addition, the drug is optimized to reduce binding to Fc receptors, and AstraZeneca says this minimizes the risk of virus-specific antibodies promoting rather than inhibiting infection and disease.
“PROVENT data show that a dose of AZD7442 administered in a convenient intramuscular injection form can quickly and effectively prevent symptomatic COVID-19,” said Myron Levin, a professor of pediatrics and medicine at the University of Colorado School of Medicine and the lead researcher of the disease in a clinical trial. Said in a prepared statement. “With these exciting results, AZD7442 may become an important tool in our arsenal to help those who may need a vaccine other than those who may need a vaccine to return to normal life.”
In addition to the clinical trial data for the prevention of Covid-19, AstraZeneca stated that preliminary laboratory test results from the University of Oxford and Columbia University indicate that the drug can neutralize variants of SARS-CoV-2, including the delta strain. AstraZeneca said it will submit the complete results of the PROVENT clinical trial for publication in peer-reviewed medical journals; they will also present them at an upcoming medical conference.
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