AstraZeneca plc AZN announced that it is set to initiate two phase III studies in next few weeks to evaluate AZD7442, a monoclonal-antibody combination for the prevention and treatment of COVID-19.
One study will evaluate AZD7442 for the safety and efficacy to prevent COVID-19 infection for up to 12 months while another will evaluate the candidate for post-exposure prophylaxis and pre-emptive treatment of the deadly coronavirus. The company is also planning to initiate additional studies to evaluate AZD7442 for the treatment of COVID-19.
We note that the company is progressing with the development of AZD7442 at an accelerated pace following the initiation of its phase I study in August 2020. AZD7442 is a combo of two monoclonal antibodies, AZD8895 and AZD1061, which were derived from convalescent patients with SARS-CoV-2 infection. The company in-licensed the same from Vanderbilt University in the United States during June.
Moreover, AstraZeneca secured a funding support of around $486 million under an agreement for the development and supply of AZD7442 in the United States. The funding agreement was signed with the Biomedical Advanced Research and Development Authority ("BARDA") and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. Per the terms of this deal, AstraZeneca will deliver up to 100,000 doses beginning this year-end. The U.S. government is also eligible for another one million doses in 2021, under a separate contract.
In July, the UK government announced an agreement in principle with AstraZeneca for the supply of one million doses of AZD7442 with deliveries anticipated to start as early as the first half of 2021, should AZD7442 prove to be well-tolerated and effective in clinical studies.
Shares of AstraZeneca shares have risen 9.8% so far this year compared with the industry’s increase of 0.5%.
Significantly, AstraZeneca is also developing a coronavirus vaccine candidate AZD1222 in partnership with Oxford University in several late-stage studies across the globe. However, the U.S. phase III study is placed under a clinical hold by the FDA.
Meanwhile, several other pharmaceutical companies are developing treatments for COVID-19. Gilead’s GILD Veklury (remdisivir) is the only antiviral treatment to get an Emergency Use Authorization (“EUA”) for the COVID-19 infection. Further, multiple ongoing international phase III studies are evaluating the safety and efficacy of remdesivir for addressing the SARS-CoV-2 infection.
Earlier this month, Regeneron REGN and Eli Lilly LLY submitted a request to the FDA for an EUA of both their experimental COVID-19 treatments, namely REGN-COV2 and LYCoV555, respectively.
Regeneron’s antibody treatment was recently hailed by President Donald Trump who was administered the same after he tested COVID-19 positive. Moreover, the company signed an agreement with the BARDA and the Department of Defense Joint Program receiving a funding worth $450 million to manufacture and supply REGN-COV2.
Additionally, Vir Biotechnology along with partner Glaxo is evaluating their monoclonal antibody candidate VIR-7831 for the early treatment of COVID-19 in a phase III study.
AstraZeneca PLC Price
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AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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