(Sharecast News) - AstraZeneca announced on Monday that its long-acting antibody (LAAB) combination for Covid-19, AZD7442, would advance into two phase 3 clinical trials in more than 6,000 participants both in and outside the US in the coming weeks.
The FTSE 100 pharmaceuticals giant said the LAABs had been engineered with its proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration.
It said the combination of two LAABs were also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.
The company said it had received support of around $486m (£372.51m) from the US government for the development and supply of AZD7442, under an agreement with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
One trial would evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months, in around 5,000 participants.
The second trial would evaluate post-exposure prophylaxis and pre-emptive treatment in about 1,100 participants.
AstraZeneca said it was planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of Covid-19.
It said it planned to supply up to 100,000 doses towards 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 chief executive officer Pascal Soriot.
"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."
The firm said LAABs mimicked natural antibodies, and had the potential to treat and prevent disease progression in patients already infected with the virus, as well as to be given as a preventative intervention prior to exposure to the virus.
A LAAB combination could be complementary to vaccines as a prophylactic agent, for example for people for whom a vaccine might not be appropriate, or to provide added protection for high-risk populations.
It could also be used to treat people who had been infected.
AstraZeneca said the agreement built on previous funding of more than $25m from US government agencies for the discovery and evaluation of the monoclonal antibodies, as well as the phase 1 clinical trial started in August to assess safety, tolerability and pharmacokinetics of AZD7442 in healthy individuals.
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