AstraZeneca says its antibody cocktail AZD7442 has shown positive results against Covid-19 in Phase III clinical trials.
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AstraZeneca’s antibody treatment has been shown to be highly effective in preventing Covid-19 in people who may not respond well to vaccines, according to new clinical trial results.
The results showed that patients who received a single injection of the antibody treatment known as AZD7442 were 83% less likely to develop symptomatic cases of the coronavirus than participants who received a placebo.
An earlier analysis of the study, done three months after administering the treatment, had shown that the risk of developing serious illness was reduced by 77%.
Six months after administration of treatment, no severe cases of Covid-19 or death from the virus had been recorded in patients receiving the antibody cocktail. In a group that received the placebo, five participants developed severe Covid-19 and there were two Covid-related deaths within six months of starting the study.
More than 75% of study participants had underlying medical conditions that made them at high risk of developing severe Covid-19 disease, including those whose immune systems were weakened and who may therefore be less responsive to vaccination.
According to AstraZeneca, there is a risk that around 2% of the world’s population will not respond well to Covid-19 vaccines. This includes people undergoing dialysis treatment, undergoing chemotherapy, and people taking immunosuppressive drugs for conditions such as rheumatoid arthritis.
The phase 3 clinical trial was conducted at 87 sites in five countries: the US, UK, Spain, Belgium and France. A total of 5,197 people took part, with 3,460 300 mg AZD7442 and 1,737 receiving a saline placebo.
The six-month assessment included data from 4,991 participants, with those who left the study to get vaccinated were excluded from data analysis. The subjects are assessed for a further 15 months.
In a separate study, patients with mild to moderate Covid-19 who received a dose of AZD7442 within three days of symptoms appearing reduced the risk of developing serious illness by 88%.
Half of the 903 participants in this study received 600 mg of AZD7442, while the other half received a placebo.
Ninety percent of those included in the second study were considered to be at high risk of developing severe Covid-19 if they contracted the virus.
The full results of the study have not yet been peer-reviewed but are being submitted for publication in a medical journal.
AstraZeneca said both studies showed that AZD7442is “generally well tolerated”.
“These compelling results give me the confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they desperately need to finally get back to their daily routine,” said Hugh Montgomery, professor of intensive care medicine at University College London and principal investigator in the studies said in a press release Thursday.
“What is important is that despite the rise in the delta variant, those high-risk participants who may not respond adequately to vaccination have been given six months of protection.”
Meanwhile, Mene Pangalos, Executive Vice President of Biopharmaceuticals Research and Development at AstraZeneca said that AZD7442 is the only long-acting antibody with Phase III data to demonstrate its effectiveness in both the prevention and treatment of Covid-19 19 to be assigned a dose.
“We are advancing on approval applications around the world and look forward to providing an important new option against SARS-CoV-2 as soon as possible,” he said.
Other companies developing antibody treatments include GSK, Regeneron, and Eli Lilly. All three have been approved by the FDA for emergency use.
In October, AstraZeneca announced that it had asked the FDA for an emergency approval for AZD7442 as a preventive treatment. It has not yet been granted.
The pharmaceutical giant has agreed to deliver 700,000 doses of its antibody treatment to the US government if this request is granted. There are also agreements for the delivery of AZD7442 to other countries.