" class="no-js "lang="en-US"> AZD7442 Reduced Risk of Developing Severe COVID-19 or Death in TACKLE Phase III Outpatient Treatment Trial - Medtech Alert
Thursday, February 09, 2023

AZD7442 Reduced Risk of Developing Severe COVID-19 or Death in TACKLE Phase III Outpatient Treatment Trial

Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca‘s AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.

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

The 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 (from any cause) 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 LAAB was generally well tolerated in the trial.

In a prespecified analysis of participants who received treatment within five days of symptom onset, AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) 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.

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, and TACKLE principal investigator, said: “With continued cases of serious COVID-19 infections across the globe, there is a significant need for new therapies like AZD7442 that can be used to protect vulnerable populations from getting COVID-19 and can also help prevent progression to severe disease. These positive results show that a convenient intramuscular dose of AZD7442 could play an important role in helping combat this devastating pandemic.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19. An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months.”

TACKLE included 903 participants in a 1:1 randomisation AZD7442 to placebo. The primary analysis was based on 822 participants.

AstraZeneca will be discussing the data with health authorities. On 5 October 2021, the Company 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.

Full results from TACKLE will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.

People In This Post

Companies In This Post

  1. ReviR Therapeutics and Asieris Pharmaceuticals Enter into Agreement to Discover Oncology Therapeutics Read more
  2. Superior HealthPlan and eFamilyCare Expand Partnership to Support Medicaid Members and Caregivers in Texas Read more
  3. Garuda Therapeutics Secures $62 Million Series B Financing to Advance Off-the-Shelf Blood Stem Cell Technology Platform Read more
  4. FSD Pharma Receives Regulatory Clearance for Its Proposed Phase-1 Clinical Trial of Lucid-21-302 (Lucid-MS), First-in-Class Multiple Sclerosis Drug Candidate Read more
  5. $25 Million Gift to Penn Medicine and Children’s Hospital of Philadelphia Establishes Center for Epilepsy and Neurodevelopmental Disorders Read more