Combination Antibody to Prevent COVID-19 Meets Primary Trial Endpoint

AstraZeneca reported its AZD7442, a combination of 2 LAAB, reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo in its PROVENT phase 3 clinical trial. AZD7442 is a combination of tixagevimab (AZD8895) and cilgavimab (AZD1061), and derived from B-cells donated by convalescent patients after SARS-CoV-2 virus.

The primary analysis was completed with 5172 participants who did not have SARS-CoV-2 infection at baseline.

“The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19,” principal trial investigator Myron J. Levin, MD, professor of Pediatrics and Medicine, University of Colorado School of Medicine, 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.”

The phase 3 trial is a randomized, double-blond, placebo-controlled, multicenter study that has been assessing the safety and efficacy of AZD7442 using a 300mg single-dose compared to placebo in preventing COVID-19. Sites included the US, UK, Spain, France, and Belgium. 5197 participants were randomized in a 2:1 ratio to receive a single intramuscular dose of either AZD7442 (n = 3460) or saline placebo (n = 1737), administered in 2 separate, sequential injections.

Approximately 43% of participants were 60 years and over. In addition, more than 75% had baseline co-morbidities and other characteristics that are associated with an increased risk for severe COVID-19 should they become infected, including those with immunosuppressive disease or taking immunosuppressive medications, diabetes, severe obesity or cardiac disease, chronic obstructive pulmonary disease, chronic kidney and chronic liver disease.

The company see the significance of having additional methods to prevent COVID-19, especially with those who are immunocompromised or have serious underlying health conditions and may need supplemental approaches to provide additional protection.

“We need additional approaches for individuals who are not adequately protected by COVID-19 vaccines. 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,” AstraZeneca Executive Vice President, BioPharmaceuticals R&D, Mene Pangalos, said. “We look forward to sharing further data from the AZD7442 phase 3 clinical trial program later this year.”