The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline (GSK) and Vir Biotechnology’s investigational dual-action monoclonal antibody (mAb) VIR-7831 for the early treatment of COVID-19.
According to GSK, the review will include an interim analysis of efficacy and safety data from the Phase III COMET-ICE trial.
In this trial, VIR-7831 monotherapy was evaluated for the early treatment of COVID-19 in adults who are at high risk of progressing to severe disease.
An interim analysis, based on data from 583 randomised patients, demonstrated an 85% reduction in hospitalisation or death for those who received the mAb compared to placebo.
Following this result, the Independent Data Monitoring Committee recommended that enrolment into the trial be stopped, based on evidence of ‘profound efficacy’.
In addition, preclinical data suggests VIR-7831 targets a highly conserved epitope of the SARS-CoV-2 spike protein, potentially making it more difficult for resistance to build up.
On top of that, new in vitro data published on the preprint server bioRxiv from pseudotyped virus assays demonstrate that VIR-7831 maintains activity against currently circulating variants of concern – including those discovered in the UK, South Africa and Brazil.
Further studies evaluating GSK/Vir’s mAb include the Phase II COMET-PEAK trial which is assessing intramuscularly (IM) administered VIR-7831 compared to intravenously (IV) administered VIR-7831 in low-risk adults with mild-to-moderate COVID-19.
GSK and Vir are also planning two additional Phase III trials – COMET-TAIL and COMET-STAR – which will assess IM-administered VIR-7831 in high-risk adults with COVID-19 and a prevention trial in high-risk adults taking IM-administered VIR-7831.
An emergency use application (EUA) for VIR-7831 has also been submitted to the US Food and Drug Administration (FDA), GSK said in a statement.