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AstraZeneca started late-stage trials on November 21 of an experimental long-acting monoclonal antibody combination drug it hopes could be utilised as a so-called prophylactic to prevent COVID-19 infection in at-risk individuals for up to 12 months.
The Phase III global clinical trial will recruit a total of 5,000 people across countries in Europe and the United States to evaluate the safety and efficacy of the antibody cocktail, called AZD7442.
The prophylactic treatment differs from a vaccine since it introduces antibodies, rather than prompting the body’s immune system to create them. It may prove useful in people whose immune systems are weaker or compromised, and who do not respond to vaccination. Separately, AstraZeneca is developing a COVID-19 vaccine in conjunction with researchers at Oxford University.
In Britain, where the trials of this monoclonal antibody combination kicked off on November 21, 1,000 participants will be recruited at nine sites, researchers leading the UK arm said.
“What we are exploring in this research is whether we can provide protection by giving antibodies which have been shown to neutralise the virus, by injection into the muscle,” explained Andrew Ustianowski, a professor and chief investigator on the UK study.
“The hope is that this will provide decent protection for many months against infection.”
Monoclonal antibodies mimic natural antibodies that the body generates to fight off disease. They can be synthesised in the laboratory and are already used to treat some kinds of cancer.
AstraZeneca said its COVID-19 cocktail — that unites two monoclonal antibodies — has the capacity both to treat and prevent disease progression in patients already infected with the SARS-CoV-2 virus, also to be given as a preventative medication prior to people like healthcare workers being exposed to the virus.
“All these have been engineered specifically to have what we call a long half-life, (so) we believe they will confer protection for (at least) six, but more likely closer to 12 months,” Mene Pangalos, AstraZeneca’s executive vice president of biopharmaceuticals R&D, told reporters in a briefing.
He said this made the cocktail,”in effect, almost like a passive vaccination.”
Alongside the 5,000-participant trial assessing the drug’s potential as a preventative, AstraZeneca also intends to evaluate AZD7442 as a post-exposure preventative and pre-emptive treatment in roughly 1,100 participants in trials in Europe and the United States.
The UK government also has an in-principle agreement with AstraZeneca which it states secures access to a million doses of AZD7442 if it is effective in Phase III trials.
Under a plan to set up a global production network, Astra in October enlisted contract manufacturer Lonza to make the drug in Portsmouth, New Hampshire, beginning in the first half of 2021.
