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Sunday, October 24th, 2021

Astra-Zeneca COVID-19 antibody therapeutic shows promise in Phase 3 trial

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Results of a Phase 3 clinical trial have shown that AstraZeneca’s antibody combination for COVID-19, AZD7442, cuts the risk of symptomatic COVID-19 cases by 77 percent for at least three months.

That is dependent on the treatment being taken prior to infection. However, the antibodies used in the PROVENT trial proved to be consistently safe and well-tolerated, and their protection manifested after a single dose distributed between two intramuscular injections, rendered over the course of the same visit. This data was based on the analysis of 5,197 volunteers in the U.S. and Europe, including those with suppressed immune systems and other high risk individuals.

“The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19,” Dr. Myron Levin, professor of Pediatrics and Medicine at the University of Colorado School of Medicine, and principal investigator on the trial, said. “With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives.”

AstraZeneca began testing of AZD7442 with the support of the Biomedical Advanced Research and Development Authority (BARDA). Along the way, BARDA offered $146.2 million for late-stage development, expert advice and funding for production. Although clinical participants’ will be studied for the next 15 months to determine how long the antibodies’ protection lasts, BARDA and the Department of Defense have already agreed to purchase up to 600,000 doses of the antibody combination if the Food and Drug Administration grants it emergency use authorization.

While vaccines are still the preferred route for most eligible patients, antibody combinations like AZD7442 are meant to help provide protection to those with health conditions that prevent them from getting those vaccines, or who are at high risk of infection because of compromised immune responses. The two antibodies involved in this particular combination were discovered by Vanderbilt University and licensed to AstraZeneca.

“We need additional approaches for individuals who are not adequately protected by COVID-19 vaccines,” Mene Pangalos, executive vice president of AstraZeneca BioPharmaceuticals R&D, said. “We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines.”

All participants in the trial were at least 18 years old.