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AstraZeneca : Phase III Trial Shows AZD7442 Reduces Risk Of Developing Severe COVID-19 Or Death

AstraZeneca's (AZN,AZN.L) long acting antibody or LAAB combination, AZD7442, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic COVID-19, as per results from the TACKLE Phase III COVID-19 treatment trial.

The late-stage trial met the primary endpoint, with a dose of 600mg of AZD7442 given by intramuscular (IM) injection reducing the risk of developing severe COVID-19 or death by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.

The trial recorded 18 events in the AZD7442 arm (18/407) and 37 in the placebo arm (37/415). The long acting antibody or LAAB was generally well tolerated in the trial.

A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.

According to the company, AZD7442 reduced the risk of developing severe COVID-19 or death by 67% compared to placebo, with nine events in the AZD7442 arm (9/253) and 27 in the placebo arm (27/251).

AZD7442 is the first LAAB with Phase III data to demonstrate benefit in both prophylaxis and treatment of COVID-19 and is easily administered by IM injection, the company said.

AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus.

Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

On 5 October 2021, AstraZeneca announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19.

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