GSK Claims New Anitbody Drug Is Effective Against Omicron
GSK has just released more data on its new COVID antibody-drug and – surprise, surprise – the company and its American partner claim there is no evidence that the drug is less effective against the omicron variant.
GlaxoSmithKline and Vir Biotechnology released the updated preclinical data early Tuesday in the US. The data showed that the pair’s investigational monoclonal antibody sotrovimab continues to show “in vitro activity” against the full known omicron spike protein, according to a statement. This includes 37 identified mutations of the spike protein. Although none of this data has been published in a peer-reviewed medical journal.
The data builds on initial preclinical data released last week showing GSK’s antibody drug retains in vitro activity against key individual mutations of the omicron variant.
But Tuesday’s data is even more encouraging.
“Given the less than three-fold neutralization shift demonstrated in the pre-clinical pseudo- virus assay, which falls below the FDA authorized fact sheet guidance of less than a 5-fold change, we are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of COVID-19,” said Vir CEO George Scangos.
GSK’s top scientist released a similarly sunny statement.
“From the outset of our collaboration with Vir we hypothesized that sotrovimab would have a high barrier to resistance and thus could deliver best-in-class potential for the early treatment of patients with COVID-19,” said Dr Hal Barron, chief scientific officer at GSK.
“These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO, and we look forward to discussing these results with regulatory authorities around the world.”
Unfortunately for the most vulnerable patients, the benefits of sotrovimab have not been seen in patients hospitalized due to a severe case COVID. Furthermore, the drug isn’t used for patients who are hospitalized or require oxygen due to the seriousness of the infection.
Sotrovimab is authorized for emergency use in the US and in Japan while temporary authorizations have been granted in a dozen countries. The companies are preparing to apply for approval in the EU as well. GSK is already filling out the application for the EMA and it has already signed an agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements, the company said.
GSK and Vir have engineered “pseudo-viruses” that feature major COVID mutations and have run lab tests showing the antibody drug’s efficacy at combating these viruses in a lab setting.
As we pointed out again yesterday, with little concrete data available on omicron, drug- and vaccine-makers have effectively been left to talk their books, so to speak. The big question now: will these treatments actually work in humans?
Tue, 12/07/2021 – 07:02
Jump To The Original Source