A new coronavirus antibody treatment developed by pharmaceutical giant AstraZeneca for people who cannot be vaccinated has reduced the risk of developing symptomatic disease by 77%, the company said.
The results of the Provent phase III pre-exposure prophylaxis trial showed that there were no cases of serious death related to Covid or Covid in people treated with the “antibody cocktail” AZD7442, AstraZeneca said on Friday.
The study of more than 5,000 adults found that AZD7442, a combination of two long-acting antibodies, also reduced the risk of developing symptomatic Covid-19 by 77% compared to placebo.
In the placebo group, there were three cases of severe coronavirus including two deaths, the company added.
The drug company said the combination of antibodies, which is given by injection into the muscle, could give people up to 12 months of protection against Covid-19.
This is the first non-vaccine antibody combination modified to provide potentially long-lasting protection that has been shown to prevent Covid-19 in a clinical trial, AstraZeneca added.
Sir Mene Pangalos, Executive Vice President of Biopharmaceutical R&D at AstraZeneca, said: “We need additional approaches for people who are not adequately protected by Covid-19 vaccines.
“We are very encouraged by these efficacy and safety data in people at high risk, showing that our long-acting antibody combination has the potential to protect against symptomatic and serious illnesses, alongside vaccines. .
“We look forward to sharing further data from the AZD7442 Phase III clinical trial program later this year.”
More than 75% of the trial participants had comorbidities and other features associated with an increased risk of severe Covid-19 or causing a reduced immune response to vaccination, AstraZeneca said.
These include people with immunosuppressive disease or taking immunosuppressive drugs, diabetes, severe obesity or heart disease, chronic obstructive pulmonary disease, chronic kidney disease, and chronic liver disease.
The long-acting antibodies were well tolerated and preliminary analyzes showed that the adverse events were balanced between the placebo and AZD7442 groups, AstraZeneca added.
AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to resume normal life
Participants will continue to be monitored for 15 months, the company said.
AstraZeneca also said preliminary “in vitro” results from investigators at Oxford University and Columbia University show AZD7442 neutralizes recent emerging strains of Covid, including the Delta variant.
Myron J Levin, professor of pediatrics and medicine at the University of Colorado School of Medicine and principal investigator of the trial, said: “Data from Provent shows that a dose of AZD7442, given in one form intramuscular convenient, can prevent Covid19 symptoms quickly and effectively.
“With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to resume normal life.”
AstraZeneca said it will prepare regulatory submissions of the data to health authorities for possible emergency use authorization or conditional approval of AZD7442.
Professor Penny Ward, visiting professor of pharmaceutical medicine at King’s College London, said the new treatment could be a very important option for patients at high risk of Covid who have responded poorly to vaccination or who need to take immunosuppressive therapy for other diseases.
This could potentially be a game-changer for these people, who are currently advised to continue to protect themselves despite being fully vaccinated.
She added: “Indeed, it could potentially be a game-changer for these people, who are currently advised to continue to protect themselves despite their full vaccination.
“Despite the success of the vaccination, some people do not respond as well and remain at a higher risk of illness, hospitalization and death. Prophylaxis with passive antibody therapy may further help these individuals and reduce morbidity and mortality in this important subset of the population.
“They can be used to protect people while they are undergoing treatment for cancer, for example.”
But Professor Ward said that while the initial data “encouraged” the full publication of the results, there was a need to understand the merits of the product and how to use it “most effectively” in practice.
Helen Rowntree, director of research, services and engagement for Blood Cancer UK, said the Medicines and Health Products Regulatory Agency (MHRA) urgently needs to assess the drug for approval for use in the UK.
If approved, the government must make plans to give it to people with blood cancer as quickly as possible, she added.
Ms Rowntree said: ‘This is great news for people with blood cancer because although their weakened immune systems mean they are less likely to respond to vaccines, this treatment does not rely on the system. immune system to produce antibodies to fight the virus.
“This means it may even be a game-changer that potentially offers people with blood cancer the same type of Covid protection that vaccines already offer people who don’t have blood cancer. “