AstraZeneca COVID-19 antibody drug offers 83% protection over six month period
pharmafile | November 18, 2021 | News story | Business Services |
New data from AstraZeneca’s COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials have revealed high efficacy from a dose of the long acting antibody (LAAB) combination.
In an analysis of the ongoing PROVENT trial, it was found that one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.
About 2% of the global population is considered to have a heightened 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 AZD7442 PROVENT trial is the first Phase III trial designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19, with targeted inclusion of high-risk and immunocompromised participants.
An analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate COVID-19, showed that one 600mg intramuscular (IM) dose of AZD7442 reduced the risk of developing severe COVID-19 or death by 88%, compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.
In both the PROVENT and TACKLE trials, AZD7442 demonstrated a good tolerability profile.
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and AZD7442 principal investigator, said: “These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives. Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added: “AZD7442 is the only long-acting antibody with Phase III data to demonstrate benefit in both pre-exposure prophylaxis and treatment of COVID-19 with one dose. These new data add to the growing body of evidence supporting AZD7442’s potential to make a significant difference in the prevention and treatment of COVID-19.”