AstraZeneca announced Friday that it will advance its experimental long-acting antibody (LAAB) combination AZD7442 into two Phase III clinical trials that are due to begin "in the next weeks." The company said it also received about $486 million in US government funding for the development and large-scale manufacturing of AZD7442 under an agreement with the Biomedical Advanced Research and Development Authority (BARDA).
According to AstraZeneca, the LAABs have been engineered with the company's half-life extension technology to prolong the durability of the therapy for six to 12 months following a single administration. It added that the cocktail of two monoclonal antibodies is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus. The company noted that a LAAB combination "could be complementary to vaccines as a prophylactic agent," such as for people for whom a vaccine may not be appropriate or as added protection for high-risk groups.
One trial will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months, in approximately 5000 participants, while the second will test its potential to prevent infection in a post-exposure prophylaxis setting among roughly 1100 subjects who have come in contact with COVID-19 patient. AstraZeneca said it is also planning additional studies to assess AZD7442 in about 4000 adults as a treatment of SARS-CoV-2 infections.
Meanwhile, AstraZeneca estimates that up to 100,000 doses of AZD7442 could be available for the US starting towards the end of 2020, and that the US government can acquire up to an additional 1 million doses in 2021 under a separate agreement.
CEO Pascal Soriot suggested that AZD7442 "has the potential to provide immediate and long-lasting effect" at both preventing and treating COVID-19 infections. He also said that testing of the LAAB combination in various settings – from prophylaxis, to outpatient treatment to hospitalisation – will be done "with a focus on helping the most vulnerable people."
AstraZeneca is currently a frontrunner for the development of a vaccine against COVID-19, dubbed AZD1222, which it is working on with the University of Oxford. Phase III testing of AZD1222 is currently ongoing, having resumed in some countries after a UK participant experienced an adverse event, although it remains on hold in the US.
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