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By RTTNews Staff Writer | Published: 10/12/2020 2:40 AM ET
AstraZeneca Plc. (AZN.L,AZN) announced Monday that its long-acting antibody or LAAB combination, AZD7442, will advance into two Phase III clinical trials for the prevention of COVID-19.
Further, the company said it has received support of around $486 million from the US Government for the development and supply of AZD7442. The US Government funding is for the development and supply of up to 100,000 doses starting towards the end of 2020. The US Government can acquire up to an additional one million doses in 2021 under a separate agreement.
The funding is received under an agreement with the Biomedical Advanced Research and Development Authority or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
AZD7442 is a combination of two LAABs derived from convalescent patients after SARS-CoV-2 infection. It was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.
The LAABs have been engineered with AstraZeneca's proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration. The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.
The company noted that the two trials will enrol over 6,000 adults for the prevention of COVID-19 at sites in and outside the US that are due to begin in the next weeks.
one trial will evaluate the safety and efficacy of AZD7442 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 approximately 1,100 participants.
AstraZeneca is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19. The additional trials will enroll around 4,000 adults for the treatment of SARS-CoV-2 infections.
AstraZeneca said the agreement is not anticipated to impact its financial guidance for 2020 as the US Government funding is being offset by expenses to progress the clinical trials of AZD7442 as well as manufacturing process and upscaling costs.
Should the Phase III trials prove successful and AZD7442 become an approved medicine, the Company anticipates providing the medicine at commercial terms during and after the current coronavirus pandemic.
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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.
Article reposted on Markethive by Jeffrey Sloe
