Evusheld from AstraZeneca (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination used in the prevention of Covid-19, was shown to retain neutralizing activity against the Omicron SARS-CoV variant -2 (B.1.1.529), according to new preclinical data.
In this study, the inhibitory concentration 50 (IC50) of Evusheld, a measure of the neutralizing power of an antibody, was measured at 171 ng / ml and 277 ng / ml in two confirmatory tests, which is in the range of range of neutralizing titers found in a person who has previously been infected with Covid-19.
The Evusheld IC50 for the original strain of SARS-CoV-2, previously referred to as the Wuhan strain, was around 1.3 ng / ml and 1.5 ng / ml, respectively.
The first data, generated by the full Omicron variant peak pseudovirus testing against the combination of tixagevimab with cilgavimab, adds to the growing body of preclinical evidence showing that Evusheld retains activity against all tested variants of concern to date. , an official statement released Friday mentioned.
The study was performed independently by researchers from the United States Food and Drug Administration (FDA), Center for Biologics Evaluation and Research. The work was supported by US government research funds.
Mene Pangalos, Executive Vice President, Biopharmaceutical R&D, AstraZeneca, said: “By combining two potent antibodies with different and complementary activities against the virus, Evusheld was designed to escape potential resistance with the emergence of new variants of the virus. SARS-CoV-2. “
Pangalos added: “Evusheld is the first long-acting antibody to receive emergency use authorization in the United States for pre-exposure prophylaxis of Covid-19, in addition to authorizations in other countries . We are working with regulators on applications for the use of Evusheld in the treatment of Covid-19. “
Further analysis to evaluate Evusheld against the Omicron variant is underway by AstraZeneca and third party laboratories, with data expected soon.
Evusheld received emergency use authorization (EUA) in the United States in December 2021 for pre-exposure prophylaxis (prevention) of Covid-19 in people with moderate to severely compromised immunity due to a medical problem or immunosuppressive drugs and who may not mount an immune response to vaccination except in people for whom vaccination is not recommended. The first doses of the drug should be available within a few days.
About 2% of the world’s population is considered to be at increased risk of an inadequate response to a Covid-19 vaccine. New evidence indicates that protecting vulnerable populations from Covid-19 could help prevent viral progression, which is an important factor in the emergence of variants.
In addition, Evusheld’s TACKLE phase III outpatient treatment trial was shown to reduce the risk of developing severe Covid-19 or death (from any cause) by 50% compared to placebo in outpatients with mild to moderate infection who had been symptomatic for seven days or less.