Vir, GSK to seek EUA for COVID-19 antibody therapy

Vir Biotechnology and GSK plan to seek emergency use authorisation for their experimental COVID-19 antibody therapy after interim data from a study showed an 85 per cent reduction in hospitalisation and deaths among patients, the companies said.

The move brings antibody therapy one step closer to becoming another weapon against the pandemic, with similar therapies from Eli Lilly and Regeneron Pharmaceuticals receiving recommendations from US and European health regulators earlier this year.

Vir and GSK said in a joint statement on Wednesday that an independent panel recommended stopping further enrollment in the late-stage trial of the therapy due to evidence of “profound efficacy”.

The companies said they plan to use the results of the study to seek emergency use authorisation from the US Food and Drug Administration and regulatory approvals in other countries.

George Scangos, CEO, Vir Biotech said in an interview with Reuters that Vir is in contract talks for the therapy with governments including the US and that the data will likely speed up their progress towards a deal.

Antibody treatments are designed to decrease the severity of COVID-19 among patients diagnosed with the infection.

Vir and GSK also said that a new laboratory study showed the therapy, VIR-7831, was equally effective against the UK, South African and Brazilian variants of the coronavirus.

Scangos said Vir is reviewing data from its study to identify which patients have variants of COVID-19 and confirm the antibody is effective against them.

“We don’t yet have data to definitely say the antibody is as effective against variants of the virus as it is against prototypic strains. It appears that way from preclinical research,” Scangos said.

Vir and GSK announced a partnership last year to research COVID-19 treatments.