AstraZeneca’s long-acting antibody (LAAB) combination AZD7442 for the treatment of COVID-19 is set to advance in two phase III clinical trials in the next few weeks.
The trials will involve over 6,000 participants at sites in and outside the US and will evaluate AZD7442 as a preventative COVID-19 treatment.
One trial is set to test the safety and efficacy of the LAAB to prevent infection for up to 12 months in approximately 5,000 participants. The second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in around 1,100 participants.
AZ is also planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19.
AZD7442 was engineered using AZ’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following the first administration.
By combining two LAABs, AZ is hoping that AZD7442 can reduce the risk of resistance developed by the SARS-CoV-2, which causes COVID-19.
Under an agreement with the US government’s Biomedical Advanced Research and Development Authority (BARDA), AZ has received support of approximately $486m for the development and supply of AZD7442.
AZ plans to supply up to 100,000 doses of AZD7442 beginning at the end of 2020, with the US government able to acquire up to an additional one million doses in 2021 under a separate agreement.
“This agreement with the US government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections,” said Pascal Soriot, chief executive officer of AZ.
“We will be evaluating the LAAB combination in different settings from prophylaxis, to outpatient treatment to hospitalisation, with a focus on helping the most vulnerable people,” he added.