A late-stage trial of long-lasting AstraZeneca antibodies showed strong results in treating those who cannot take Covid-19 vaccines or are at greater risk of contracting the virus for various reasons.
AZD7442, a combination of two long-acting antibodies, reduced the risk of developing symptomatic Covid-19 by 77%, compared to placebo, the company announced.
If successful, the treatment would help people who cannot take vaccines and remain at increased risk of the virus.
The risk has grown with the surge in cases driven by the faster-spreading Delta variant. Moreover, the situation has been made worse by low vaccination rates among young adults and signs that the virus can be spread by the fully vaccinated.
There were no cases of severe Covid-19 or Covid-19-related deaths in those treated with AZD7442. However, in the placebo arm, there were three cases of severe Covid-19, which included two deaths.
AstraZeneca was awarded nearly $500 million from the federal government to develop the antibodies. If the formula receives emergency approval, the treatment will be free.
AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated a degree of prevention of Covid-19 in a clinical trial.
AstraZeneca employs 1,500 in Delaware.
The trial included 5,197 participants. More than 75% of participants had co-morbidities, which include conditions such as obesity, diseases that require treatments that lower immunity, and diabetes.
Myron J. Levin, MD, professor of pediatrics and medicine, University of Colorado School of Medicine, and principal investigator on trial, said: “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.”
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “We need additional approaches for individuals who are not adequately protected by Covid-19 vaccines. However, 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 program later this year.”
AZD7442 used AstraZeneca’s proprietary YTE half-life extension technology, which could afford up to 12 months of protection from Covid-19, and is delivered by intramuscular injection.
AstraZeneca will 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.
The trial was conducted in 87 sites in the US, UK, Spain, France, and Belgium. 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.
AZD7442 is derived from B-cells donated by convalescent patients after getting the virus. The discovery was made by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.
