GlaxoSmithKline (GSK) and Vir Biotechnology are seeking an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for their COVID-19 a monoclonal antibody (mAb) VIR-7831 after scoring positive phase 3 trial results.
The companies announced yesterday that, after ‘evidence of profound efficacy’, the phase 3 COMET-ICE trial’s independent data monitoring committee (IDMC) recommended that enrolment into the study be stopped.
That evidence included interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% reduction in the hospitalisation or death in high-risk COVID-19 patients treated early with VIR-7831 monotherapy compared to placebo.
The trial, that will continue as a blinded trial with the existing patients, with the patients will be followed for 24 weeks, will also yield additional results when completed – this data will be ‘forthcoming’, according to GSK and Vir.
GSK and Vir will use these results to form the EUA application, and for additional authorisations in other countries.
In addition to the positive phase 3 results, GSK and Vir announced results from a new study – submitted and pending online publication on the pre-print server bioRxiv – demonstrating that VIR-7831 maintains activity against currently circulating ‘variants of concern’.
This includes the variants discovered in the UK, South Africa and Brazil.
The results are based on in vitro data from pseudotyped virus assays – according to GSK/Vir, their mAb binds to a highly conserved epitope of the spike protein, which could make it more difficult for resistance to develop.
“The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics,” said George Scangos, chief executive officer of Vir.
“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,” he added.
Last week, GSK and Vir announced that they had paused enrolment in another study of VIR-7831 – the phase 3 ACTIV-3 trial – evaluating the drug in hospitalised adults with COVID-19.
Although VIR-7831 met the initial pre-specified criteria to continue to the next phase of the trial, early sensitivity analyses of the first 300 patients enrolled in the trial have ‘raised concerns’ over the potential benefit of the drug in this setting.
As a result, the independent data and safety monitoring board (DSMB) has recommended that enrolment for the VIR-7831 arm of the trial should be paused while the data matures.