AstraZeneca ( AZN Quick Quote AZN - Free Report) announced that a phase III study evaluating AZD7442, its investigational long-acting cocktail antibody therapy, for the post-exposure prevention of symptomatic COVID-19, failed to meet the primary endpoint.
In the study called STORM CHASER, AZD7442 failed to show a statistically significant reduction in the risk of developing symptomatic COVID-19 in adult unvaccinated study participants who had a confirmed exposure to a person with a case of the SARS-CoV-2 virus within the past eight days. AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% in this patient population compared to placebo, which AstraZeneca said was not statistically significant. As many as 23 cases of symptomatic COVID-19 accrued in the AZD7442 arm compared to 17 cases in the placebo arm.
However, data from a pre-planned subgroup analysis of participants who were PCR negative at time of dosing in the study showed that treatment with AZD7442 reduced the risk of developing symptomatic COVID-19 by 73% compared with placebo. In a post-hoc subgroup analysis, in participants who were PCR negative at baseline, the risk of developing symptomatic COVID-19 more than seven days following dosing was reduced by 92% following treatment with AZD7442 versus placebo.
This data shows that the cocktail therapy was somewhat effective in people who were not infected
This year so far, AstraZeneca’s shares have risen 17.7% compared with an increase of 8.8% for the
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AZD7442 is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) Several other COVID-19 prevention and treatment studies are ongoing on AZD7442 including PROVENT, a phase III study in pre-exposure prophylaxis and TACKLE, a treatment study in preventing more severe disease in outpatient setting. The PROVENT study is expected to give more clear data on the PCR negative patient population. Though the data from the STORM CHASER study was disappointing, there is still hope that AZD7442 could be approved if data from the PROVENT and TACKLE studies prove positive.
In March, AstraZeneca signed a deal to supply the U.S. government with up to 500,000 additional doses of AZD7442 for $205 million if the candidate is granted emergency approval in post-exposure prophylaxis. In October last year, AstraZeneca got a funding support of almost $486 million from the U.S. government for supplying up to 100,000 doses of AZD7442 to the government. Meanwhile, AstraZeneca has a separate agreement to supply the Department of Defense with 100,000 doses, bringing potential U.S. supplies of AZD7442 to 700,000 in 2021. AstraZeneca is now in talks with officials regarding the next step on the U.S. government deal.
Other antibody cocktail therapies approved for emergency use for treating high-risk COVID-19 patients are
Eli Lilly’s ( LLY Quick Quote LLY - Free Report) cocktail therapy, bamlanivimab plus etesevimab and Regeneron’s ( REGN Quick Quote REGN - Free Report) antibody cocktail, REGEN-COV (casirivimab and imdevimab). Last month, FDA granted emergency approval to Vir Biotechnology and GlaxoSmithKline ( GSK Quick Quote GSK - Free Report) dual-action monoclonal antibody sotrovimab for treating mild-to-moderate COVID-19 in patients who are at risk of progression to severe COVID-19, including hospitalization or death.
In a separate press release, AstraZeneca announced that real world data showed that its COVID-19 vaccine was reasonably effective against the Delta variant (B.1.617.2; formerly the “Indian” variant), a highly contagious variant of the virus, which has become a matter of global concern. New data from Public Health England (PHE) showed that two doses of the vaccine was 92% effective against hospitalizations due to the Delta variant.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see
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