One of the world’s largest pharmaceutical companies found a novel treatment significantly reduces the chance of developing severe deadly disease symptoms on Aug. 20.
AstraZeneca confirmed antibody therapy lowers the likelihood of developing extreme COVID-19 symptoms by 77%. The company cited data from a late-stage experiment that suggests this treatment could help those who are “intolerant” or “poor” vaccine responders.
The pharmaceutical giant claimed 75% of study participants suffered from chronic illness, including a poor immunological response to vaccines.
“AZD7442 (tixagevimab and cilgavimab), a combination of two long-acting antibodies, reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval: 46, 90), compared to placebo,” the company said in a statement.
BL can reveal B cells from convalescent patients are used to make AZD7442.
Numerous COVID vaccines were applied, including one AstraZeneca produced in collaboration with Oxford University. However, attempts to create an effective therapy for infected individuals mostly failed. A June trial using the same antibody treatment in individuals, who had already been infected with the virus, failed to prevent symptoms.
When compared to the placebo, the medication was only 33% effective among those who had already been exposed to the virus. This included those were infected and tested negative. Other options for prophylactic usage were tested separately.
The U.S. Food and Drug Administration (FDA) has already approved Regeneron Pharmaceuticals’s monoclonal antibody treatment for emergency use. This happened despite competitor Eli Lilly petitioning the FDA in April to remove its emergency use authority. This was because the same antibody therapy was allegedly less effective against different virus strains. BL understands the antibody therapy in question is costly to produce and complicated to deliver.
AstraZeneca claimed there are no safety concerns because the therapy is well-tolerated. Adverse events are also evenly distributed throughout the group.
According to the manufacturer, there were no cases of severe COVID-19 or COVID-19-related fatalities in the intervention group. Three patients exhibited severe symptoms and two died in the placebo group.
Importantly, 75% of study participants had comorbidities, such as being “at risk of an inadequate response to active [immunization],” such as older individuals and those with immunosuppressive illness or who were using immunosuppressive medication.
“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,” University of Colorado School of Medicine lead investigator Myron Levin said in a statement.
PROVENT is a phase III randomized study that took place in 87 locations across the United States, United Kingdom, Spain, France, and Belgium. Adults who would “benefit from prevention” with the long-acting antibody were selected. They were unvaccinated at the time of enrolment and serologically negative for SARS-CoV-2.
A total of 5,197 people were randomly assigned to receive either a single 300 milligram dose of AZD7442 or a placebo. AstraZeneca claims 43% of the participants were aged older than 60. Diabetes, severe obesity or heart illness, chronic obstructive pulmonary disease, chronic renal disease, and chronic liver disease were among reported comorbidities. White people comprised of about 73% of the sample group.
Antibody treatment and prevention studies continue, and the entire dataset will eventually be submitted for peer-reviewed publication.