New Analyses of Two AZD7442 Covid-19 Trials Confirm Robust Efficacy and Long-Term Prevention in High-Risk Populations

New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.

In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

"AZD7442 is the only long-acting antibody with Phase III data to demonstrate benefit in both prevention and treatment of COVID-19 with one dose," said Dr. Alex Romanovschi, Vice President, Scientific Affairs, AstraZeneca Canada. "The trials have shown encouraging results for reducing the risk of developing symptomatic COVID-19 and for reducing the risk of developing severe COVID-19. We continue to work closely with Health Canada to accelerate review of the recent filing of AZD7442."

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine. This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions, including multiple sclerosis and rheumatoid arthritis.

"The fight against COVID-19 is far from over, particularly for those who aren't able to reach the same protective response following vaccination," said Kiersten Combs, President, AstraZeneca Canada. "As part of AstraZeneca's ongoing commitment to tackling this global health crisis, we are proud to see these latest results from the PROVENT and TACKLE trials as the data shows promise for offering additional protection to vulnerable Canadian populations against COVID-19."

The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for prevention of symptomatic COVID-19, with targeted inclusion of high-risk and immunocompromised participants. More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have a reduced immune response to vaccination.

An exploratory analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate COVID-19, showed that one 600mg IM dose of AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.

A total of 90% of participants enrolled in TACKLE were from populations at high risk of progression to severe COVID-19 if they became infected, including those with co-morbidities.