AstraZeneca has reported positive news from its PROVENT Phase III pre-exposure prophylaxis trial, showing that their AZD7442 treatment reduces the risk of developing symptomatic COVID-19 cases by 77 percent.
AZD7442 is not a vaccine, although it has a similar outcome, preventing people from getting really sick with the disease. It is a combination of two long-acting antibodies and it can be used by people that can’t take the vaccine or that do not get the same high immune response from the vaccine currently approved across the world.
The Phase III clinical trial’s analysis included 5,172 participants from 87 locations across the US, UK, Spain, France, and Belgium. Over three-quarters of trial participants had comorbidities, and some had conditions that reduce the immune response from vaccines. Two-thirds received the treatment, and the remaining got a placebo.
Across the trial, there were 25 cases of symptomatic COVID-19. There were no severe cases of the diseases in people treated with AZD7442. Unfortunately, there were three severe cases of COVID-19 in the placebo group, two of which resulted in death.
“The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19,” principal investigator of the trial Myron J. Levin, from the University of Colorado School of Medicine said in a statement. “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 PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19. 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,” Levin continued.
In vitro tests show that AZD7442 is also effective against emerging variants, like the Delta variant. AstraZeneca believes that the treatment offers up to 12 months of 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. We look forward to sharing further data from the AZD7442 Phase III clinical trial programme later this year,” added Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.
AstraZeneca will now publish the full result of the PROVENT trial in a medical journal for peer-review. It will also prepare the regulatory submission of the prophylaxis (PROVENT and STORM CHASER) data to health authorities for potential emergency use authorization or conditional approval of AZD7442.