GlaxoSmithKline and Vir Biotechnology announced that the experimental drug VIR-7831 was associated with an 85% reduction in hospitalisation or death compared to placebo when used for the early treatment of COVID-19 in adults at high risk of hospitalisation. The companies said they will "immediately" seek emergency-use authorisation of the dual-action SARS-CoV-2 monoclonal antibody in the US, as well as in other countries.
George Scangos, chief executive of Vir, whose shares surged as much as 58% on the news, said "these exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe." The results come shortly after GlaxoSmithKline and Vir said that another study of VIR-7831 in hospitalised adults with COVID-19 would be halted over concerns about the drug's "magnitude of potential benefit."
The latest Phase III study, called COMET-ICE, randomised adults with mild or moderate COVID-19 who are at high risk of progression to severe disease to receive a single intravenous infusion of VIR-7831 or placebo. According to GlaxoSmithKline and Vir, the trial's independent data monitoring committee (IDMC) recommended that it be stopped for enrolment due to evidence of "profound" efficacy. The decision was based on an interim analysis of data from 583 patients, with 291 receiving VIR-7831 and 292 given placebo.
The companies noted that as the trial remains ongoing, with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be available once it is completed. Scangos remarked "these findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus."
GlaxoSmithKline and Vir also highlighted new data demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African and Brazilian variants, based on in vitro data. The companies entered into a collaboration last year to develop antiviral antibodies for coronaviruses, including SARS-CoV-2, with the partnership expanded in February to include new therapies for influenza and other respiratory viruses.
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