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The multinational AstraZeneca announced this Monday positive results of the phase III Tackle clinical trial showing that AZD7442, its combination of long-acting antibodies
(tixagevimab and cilgavimab)
, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo. in non-hospitalized patients with mild or moderate symptomatic disease.
Most of the patients included in the trial were at
high risk of progression
to severe COVID-19.
Tackle included 903 participants who were randomized 1: 1 to receive the antibody or placebo treatment.
The main analysis was based on data from 822 participants.
According to information released in a press release, the trial met the primary endpoint: a 600 mg dose of AZD7442 by intramuscular injection reduced the risk of developing severe COVID-19 or death from any cause in patients by 50%. following 29 days compared to placebo.
The participants were outpatients who
had had symptoms for seven days or less
.
The trial recorded 18 events in the AZD7442 arm (18/407) and 37 in the placebo (37/415).
In general, the treatment was well tolerated in the trial.
The sooner the better
In a pre-specified 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 9 events in the AZD7442 arm (9/253) and 27 in the placebo arm (27/251).
"These important results make our product the first long-acting antibody that shows benefits both in the prevention and in the treatment of covid-19," says Ana Pérez, medical director of AstraZeneca Spain. It highlights that this trial
has participated in Spanish centers
, "which once again reinforces the quality of Spanish clinical research and the very high level of hospitals and researchers in our country."
For the laboratory spokeswoman, "AZD7442 has the
potential to make a real difference in the fight against covid-19,
along with vaccines, especially in vulnerable populations such as the immunocompromised who may not be fully protected with vaccination."
In the Tackle trial, 90% of patients had comorbidities and other characteristics that put them at high risk for progression to severe COVID-19, including cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease, or immunosuppression.
Regarding the mutations of the virus, he maintains that "the in vitro findings show that it
neutralizes the emerging viral variants of SARS-CoV-2,
including Delta and Mu."
Competitors
Other pharmaceutical companies 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 yielded
figures of reduction in hospitalization and death of between 70% and the 80%.
"There are important differences between the Tackle study and trials with other monoclonal antibodies, such as patient characteristics, study design, geography, or differences in covid-19 treatment practices, among many others, that can affect to the results, "says Pérez.
A strength of this product would be that, like vaccines, "it is easily administered by intramuscular injection", which would facilitate its use in an outpatient setting. Other competitors have exclusively developed their products intravenously. "We
await
data from additional trials, including
Activ-3, in which AZD7442 will be administered intravenously
to hospitalized patients with moderate to severe COVID-19."
The full results of the Tackle trial
will
be submitted
for publication in a peer-reviewed medical journal
and presented at an upcoming medical meeting. In addition, the company has announced its intention to share the new data with regulatory agencies as soon as possible, including the European Medicines Agency (EMA), although they do not comment on when the treatment could be authorized.
"AstraZeneca is maintaining interactions with the EMA to find the regulatory pathway that allows us to obtain
the marketing authorization in the shortest possible time
. At the same time, we are holding conversations with the authorities and institutions so that AZD7442 can arrive in Spain as soon as possible. possible, since the results of the Provent study showed that AZD7442 can significantly reduce the risk of developing COVID-1, "says the medical director.
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