It’s called pre-exposure prophylaxis. It is a well-known approach, for example, for HIV, an infection for which there is now widespread talk of ‘Prep’, which consists in the assumption by high-risk subjects of a pharmacological treatment in a preventive key, to avoid the infection. AstraZeneca has investigated this same approach for the Sars-CoV-2 coronavirus.
And today it announces “positive results” for the phase III study on the “first combination of two long-acting antibodies (Laab) to prevent Covid-19”. In this pre-exposure prophylaxis study, dubbed ‘Provent’, “AZD7442 reduced the risk of developing symptomatic Covid-19 by 77%, compared to placebo.”
AZD7442 is a combination of antibodies (non-vaccines) modified to potentially provide long-lasting protection (it could offer “up to 12 months of protection”) and is, the company points out, “the first to demonstrate Covid prevention in a clinical trial “, obtaining a” statistically significant reduction in the incidence of symptomatic Covid “, which was the primary endpoint. AstraZeneca is now preparing to submit prophylaxis data (from the Provent and Storm Chaser trials) to regulatory authorities for potential emergency use authorization or conditional approval of AZD7442.
The Provent study accumulated 25 cases of symptomatic Covid-19 at the primary analysis. There were no serious Covid cases or Covid deaths in the AZD7442 group. In the placebo arm, there were three severe cases, which included 2 deaths. The study had 5,197 participants in total (with the antibody mix group having double numbers compared to the placebo arm). More than 75% had comorbidities, including conditions that cause reduced immune response to vaccination. The antibody mix was “well tolerated,” AstraZeneca reports in a note, and preliminary analyzes show that adverse events were balanced between the placebo and AZD7442 groups.
“The data – explains Myron J. Levin, professor of pediatrics and medicine at the University of Colorado School of Medicine (USA) and principal investigator of the study – show that a dose of AZD7442, administered intramuscularly, can quickly and effectively prevent Covid. symptomatic”. This, he continues, promises to be “an important tool in our arsenal to help people who may need more than one vaccine to return to their normal lives.”
“We need additional approaches for people who are not adequately protected by Covid vaccines – echoes Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D – We are very encouraged by these efficacy and safety data in high-risk people, which show that the combination of long-acting antibodies has the potential to protect against symptomatic and severe disease, along with vaccines. We look forward to sharing more data from the Phase III clinical trial program later this year. ”
From preliminary ‘in vitro’ results by researchers at Oxford University and Columbia University, AZD7442 has been shown to “neutralize the recent emerging variants of Sars-CoV-2, including Delta,” the note reads. The complete results of the Provent trial will be sent for publication in a peer-reviewed medical journal and presented at an upcoming medical meeting.