After filing for authorization of its Covid-19 antibody as a prophylactic, AstraZeneca pulls out new data in the treatment setting
Less than a week after AstraZeneca made its pitch to the FDA for emergency use of its monoclonal antibody combo for Covid-19 prophylaxis, the British pharma is following up with data that show the drug’s potential as a treatment as well.
AZD7442 reduced the risk of severe Covid-19 or death by 50% compared to placebo in a group of 407 outpatients who were given the antibody within seven days of developing symptoms, AstraZeneca revealed on Monday. That adds up to 18 events in the treatment arm, and 37 in the placebo arm.
In a prespecified group of patients who received the treatment within five days of symptom onset, AZD7442 reduced the risk of severe disease of death by 67%, the pharma reported.
A total of 903 patients enrolled in the Phase III TACKLE study, spanning Brazil, the Czech Republic, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Ukraine, the UK and the US. About 13% of participants were 65 years or older, and 90% had comorbidities that put them at a higher risk of severe Covid, including cancer, diabetes, chronic lung disease or asthma, obesity, cardiovascular disease or immunosuppression.
“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” executive VP of biopharmaceuticals R&D Mene Pangalos said in a statement.
AstraZeneca says it will discuss the data with health authorities, but didn’t offer up a timeline for an EUA submission in the treatment setting.
The pharma filed AZD7442 for authorization as a prophylactic on Oct. 5, a month after reporting that the antibody combo was 77% effective at preventing symptomatic Covid-19 compared to placebo. However, it’s unclear how the FDA may view the trial’s relatively small sample size. And despite the positive efficacy results, VP and head of microbial sciences and biopharmaceuticals R&D Mark Esser stressed that AZD7442 is intended for use on top of vaccination, not in lieu of it.
AZD7442 was discovered by the Vanderbilt University Medical Center, and licensed to AstraZeneca last June. It’s a combination of the antibodies tixagevimab and cilgavimab, derived from B cells donated by a husband and wife team who had recovered from Covid-19.
Back in June, the antibody combo missed the mark in a study assessing its ability to prevent symptoms in adults who had a confirmed exposure to Covid-19, though AstraZeneca says the antibody combo performed better in a pre-planned analysis of PCR-negative volunteers.
“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,” principal investigator Hugh Montgomery said in a statement on Monday.
It’s been over a month since federal officials restarted distribution of Eli Lilly’s antibody combo — bamlanivimab and etesevimab — which had been taken off the market due to a “sustained increase” of certain coronavirus variants in the US.