AstraZeneca to advance AZD7442 into phase 3 Covid-19 trials
AstraZeneca said that AZD7442, which is being developed for the prevention and treatment of Covid-19, will move into two phase 3 clinical trials.
AZD7442 is a combination of a couple of monoclonal antibodies (mAbs) extracted from convalescent patients with SARS-CoV-2 infection. It will be assessed in more than 6,000 participants at sites in and outside the US that are slated to commence in the coming weeks.
One of the two late-stage trials will assess the safety and efficacy of AZD7442 in the prevention of Covid-19 for up to 12 months, in nearly 5,000 participants. The second phase 3 clinical trial will assess post-exposure prophylaxis and pre-emptive treatment in nearly 1,100 participants.
AstraZeneca is planning some more trials to study AZD7442 in nearly 4,000 patients for the treatment of Covid-19.
The long-acting antibody (LAAB) combination has been engineered with AstraZeneca’s half-life extension technology to increase its durability for 6-12 months following a single administration.
According to AstraZeneca, the combination of two LAABs is also designed for cutting down the risk of resistance developed by the SARS-CoV-2 virus.
The pharma giant had licensed the monoclonal antibody combination in June 2020 from US-based Vanderbilt University Medical Center.
AstraZeneca had secured funding support of nearly $486 million from the US government towards the development and supply of the long-acting antibody combination under an agreement with the Biomedical Advanced Research and Development Authority (BARDA).
The pharma giant will look to supply up to 100,000 doses starting towards the end of this year. Under a separate agreement, the US government can acquire up to an additional one million doses next year of the long-acting antibody combination.
Pascal Soriot – CEO of AstraZeneca said: “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.
“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.”