AstraZeneca Begins Phase 1 Trials Of COVID-19 Antibody Treatment Amid Reports Of Vaccine Emergency Approval
AstraZeneca (AZN) announced that it has started Phase 1 trials of its monoclonal antibodies for treatment and prevention of COVID-19.
The trial is being conducted with 48 healthy patients aged 18 to 55 in the U.K. The Phase 1 clinical trial was funding by the Defense Advanced Research Projects Agency of the U.S. Department of Defense and the Biomedical Advanced Research and Development Authority.
AstraZeneca said it will move the antibody treatment to larger, late-stage Phase 2 and Phase 3 trials should the treatment prove tolerable and have favorable safety results.
The antibody test, known as AZD7442, mimics natural antibodies and can be given to those individuals that have been exposed to the virus. It can also treat and prevent the progression of COVID-19 for those individuals that have been infected with the virus.
The AZD7442 treatment uses antibodies from patients that have been infected with COVID-19 and is expected to provide protection from COVID-19 for at least six months, the company said. Data from the trial is expected in the second half of 2020.
“This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said in a statement. “This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance.”
The news of the Phase 1 trial of the antibody treatment comes as a report from Financial Times indicated that the Trump administration may approve AstraZeneca’s COVID-19 vaccine before the election if results of the late-stage clinical trial prove successful. AstraZeneca said it hasn’t talked to the U.S. government about emergency authorization of the vaccine, Politico reported.
The company told Politico in a statement: “It would be premature to speculate on that possibility.”
In a $1.2 billion deal with AstraZeneca, the U.S. will take an order of 300 million doses of the vaccine when approved by the FDA.
President Donald Trump has urged the FDA to speed up the approval of a COVID-19 vaccine, Politico reported. Recently, the Trump administration has taken away the FDA’s need to approve lab-developed COVID-19 tests to improve the speed of which these tests get delivered to the public.
It is unclear if the FDA is buckling under the pressure from the administration. On Monday, it approved the use of blood plasma to treat coronavirus patients after delaying the emergency use authorization for the treatment.
Shares of AstraZeneca were trading at $57.20 as of 9:53 a.m. EDT, up 44 cents of 0.77%.
© Copyright IBTimes 2024. All rights reserved.