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Vir/GSK's COVID-19 Antibody Therapy Cuts Hospitalization, Deaths by 85%, Seeks FDA Emergency Use Nod

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An Independent Data Monitoring Committee (IDMC) has recommended that the Phase 3 COMET-ICE trial, evaluating VIR-7831 (GSK4182136) as monotherapy for COVID-19, stop enrollment due to evidence of profound efficacy.

  • The antibody treatment is being developed under a collaboration between Vir Biotechnology Inc's (NASDAQ: VIR) and GlaxoSmithKline Plc' (NYSE: GSK).

  • The IDMC recommendation was based on an interim analysis of data from 583 patients, which demonstrated an 85% reduction in hospitalization or death in the VIR-7831 arm compared to placebo, the primary endpoint of the trial.

  • VIR-7831 was well tolerated. The trial remains ongoing and blinded, with patients continuing to be followed for 24 weeks.

  • Additionally, the companies said a new laboratory study showed the therapy, VIR-7831, was equally effective against the UK, South African, and Brazilian variants of the virus.

  • Based on the findings, VIR and GSK now plan to seek emergency use authorization (EUA) for the COVID-19 antibody therapy.

  • Last week, IDMC recommended closing enrollment in the VIR-7831 arm in NIH-sponsored ACTIV Program Phase 3 trial in hospitalized adults with COVID-19.

  • Sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.

  • Price Action: VIR shares are trading 38.6% higher at 65, while GSK shares are 0.06% lower at $35.58 in premarket trading on the last check Thursday.

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