The Multinational AstraZeneca has announced positive results of the Phase III Tackle clinical trial that show that AZD7442, its combination of prolonged-acting antibodies (TIXAGEVIMAB and CILGAVIMAB), achieved a statistically significant reduction in Covid-19 severe or death compared to placebo In non-hospitalized patients with slight or moderate symptomatic disease.
Most patients included in the trial presented a high risk of progression to severe Covid-19. TACKLE included 903 participants who were randomly assigned 1: 1 to receive treatment with antibodies or placebo. The main analysis was based on the data of 822 participants.
According to the information given in a press release, the trial reached the main assessment criterion: a dose of 600 mg of Azd7442 in intramuscular injection reduced by 50% the risk of developing severe COVID-19 or death by any cause in the Next 29 days compared to placebo. The participants were ambulatory patients who had symptoms for seven days or less. The trial recorded 18 events in the arm of AZD7442 (18/407) and 37 in the placebo (37/415). In general, the treatment was well tolerated in the trial.
In a pre-specified analysis of participants who received treatment within five days after the start of symptoms, AZD7442 reduced the risk of developing severe Covid-19 or death by any cause by 67% compared to placebo, with 9 events in The arm AZD7442 (9/253) and 27 on the placebo arm (27/251).
"These important results convert our product into the first prolonged action antibody that demonstrates benefits in both prevention and treatment of Covid-19," says Ana Pérez, Medical Director of Astrazeneca Spain. She highlights that this essay has participated Spanish centers, "which once reinforces the quality of Spanish clinical research and the very high level of hospitals and researchers in our country."
With regard to virus mutations, it maintains that "the findings in vitro demonstrate that it neutralizes the emerging viral variants of SARS-COV-2, including delta and MU".
Other pharmaceuticals such as Lilly, GSK / VIR Biotechnology and Regeneron / Roche have also developed synthetic antibodies that aspire to position themselves in the prevention and treatment of COVID-19 and have thrown reduction figures in hospitalization and death between 70% and the 80% "There are important differences between the TACKLE study and the trials with other monoclonal antibodies, such as the characteristics of the patient, the design of the study, the geography or the differences in the treatment practices of the COVID-19, among many others, which can affect To the results, "says Pérez.
A strong point of this product would be that, like vaccines, "it is easily administered by intramuscular injection," which would facilitate its use in an outpatient environment. Other competitors have exclusively developed their products via intravenously. "We expect additional test data, including Activ-3, in which AZD7442 will be administered intravenously at patients hospitalized with moderate to severe".
The full results of the TACKLE trial will be sent for publication in a peer-reviewed medical journal and will be presented at a next medical meeting. In addition, the company has announced its intention to share new data with regulatory agencies as soon as possible, including the European Medicines Agency (EMA), although they are not pronounced on when the authorized treatment could be.
"AstraZeneca is maintaining interactions with the EMA to find the regulatory way that allows us to obtain the marketing authorization within the shortest possible time, in parallel, we are maintaining talks with the authorities and institutions so that AZD7442 can reach Spain before Possible, since, the results of the Provent study, showed that AZD7442 can significantly reduce the risk of developing COVID-1, "says the medical director.Updated Date: 15 October 2021, 18:14