AstraZeneca’s long-acting antibody combination is both able to prevent and treat Covid-19, according to the phase three results released on Monday.
The drug, AZD7442, is a combination of two antibodies — tixagevimab (AZD8895) and cilgavimab (AZD1061) — which is derived from B-cells donated by convalescent patients after being infected with the SARS-CoV-2 virus, the company said in a statement.
The phase III trial conducted in 96 sites in Brazil, Czech Republic, Germany, Hungary, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Ukraine, UK and US, included 903 participants who were administered a dose of 600mg of AZD7442 given by intramuscular (IM) injection.
The results showed that the cocktail reduced the risk of developing severe Covid-19 or death (from any cause) by 50 per cent compared to placebo in outpatients who had been symptomatic for seven days or less, the company said.
The drug was well tolerated in the trial.
“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,” said Hugh Montgomery, Professor of Intensive Care Medicine at University College London, in the statement.
In the participants who received treatment within five days of symptom onset, AZD7442 reduced the risk of developing severe Covid-19 or death (from any cause) by 67 per cent compared to placebo.
AZD7442 is the first cocktail with Phase III data to demonstrate benefits in both prophylaxis and treatment of Covid-19 and is easily administered by IM injection, the company said.
“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
AstraZeneca will be discussing the data with health authorities. The drug maker has also announced submission to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of Covid-19.
The results from the trial will also be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting, the company said.