AstraZeneca releases Phase 3 results of its antibody treatment, revealing it as effective at reducing severe COVID and deaths.
Over the course of the pandemic, scientists have explored multiple therapeutic options for SAR-CoV-2. The search for a cure has led to the approval of various drugs, including monoclonal antibodies. Even the World Health Organization (WHO) has added an antibody treatment onto its list of drugs for COVID-19. Acceptance of antibody therapy has largely stemmed from various trials showing their effectiveness at reducing deaths and hospitalizations. Now another antibody combination could soon join the list of approved treatments.
Earlier this month, AstraZeneca released a press release, announcing its request to the FDA for an emergency use authorization (EUA) of its new antibody treatment. The long-acting antibody combination (LAAB), also called AZD7442, contains two monoclonal antibodies – tixagevimab and cilgavimab. These antibodies bind to different sites on the coronavirus’s spike protein; thus, stopping it from entering cells. Researchers isolated these antibodies from B cells of COVID survivors and then grew more of them in the lab. Moreover, compared to other antibodies, AstraZeneca’s antibodies are modified to persist for longer in the body.
The pharmaceutical company’s EUA request is based on the results from the PROVENT phase III trial.
Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca
The PROVENT Phase III Trial
The PROVENT phase III pre-exposure prophylaxis trial assessed the efficacy of the new combination in reducing the incidence of symptomatic infection. Researchers recruited over 5,000 participants aged 18 years and above. More than 75% of the participants had risk factors of severe disease; they either suffered from comorbids like diabetes and kidney disease or took immunosuppressive medication. Participants either received a single intramuscular dose of either 300mg of AZD7442 or a placebo, administered in two separate, sequential IM injections.
Results showed a 77% reduced risk of developing symptomatic COVID, compared to the placebo group. Furthermore, the treatment did not cause any adverse events among the AZD7442 group.
If approved, AstraZeneca’s antibody treatment will be the first LAAB to receive an EUA for COVID-19.
Source: AstraZeneca
