AstraZeneca released more data indicating its AZD7442 long-acting antibody shot led to a reduction in deaths in non-hospitalized patients with mild-to-moderate symptoms.
A total of 90% of participants in the late-stage study were from populations at high risk of moving to severe virus cases.
A dose of AZD7442 given by muscle injection reduced the risk of developing severe Covid-19 or death (from any cause) by 50% compared to placebo in outpatients who had been showing symptoms for seven days or less.
In an analysis of participants who received treatment within five days of showing symptoms, AZD7442 reduced the risk of developing severe Covid-19 or death from any cause by 67% compared to placebo.
AZD7442 is the first long-acting antibody treatment with Phase III data demonstrating a benefit in both the prevention and treatment of Covid. It comes with the advantage of using an injection rather than intravenous infusion used in monoclonal antibody treatment.
Due to outbreaks of the virus in the U.S., the supply of monoclonal antibodies has tightened, with the federal government rationing supplies and some states harder hit by the virus claiming they were being discriminated against.
Infusions also require more health care resources as infusions have to be set up and monitored.
There has also been discussion over whether the treatments should first go to unvaccinated individuals who contract the virus rather than the vaccinated who get “breakthrough” cases.
Hugh Montgomery, professor of intensive care medicine at University College London and TACKLE trial principal investigator, said: “With continued cases of serious Covid-19 infections across the globe, there is a significant need for new therapies like AZD7442 that can be used to protect vulnerable populations from getting COVID-19 and can also help prevent progression to severe disease. These positive results show that a convenient intramuscular dose of AZD7442 could play an important role in helping combat this devastating pandemic.”
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for the use of this therapy in both prevention and treatment of COVID-19. An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months.”
The TACKLE trial included 903 participants. The primary analysis was based on 822 participants.
Last week, the company announced that it had submitted a request to the U.S. Food and Drug Administration for Emergency Use Authorisation for AZD7442 for preventative treatment of Covid-19.
AstraZeneca employs 1,500 in northern Delaware in headquarters, logistics, and manufacturing areas.