U.S. Markets closed
  • S&P 500

    4,411.79
    +44.31 (+1.01%)
     
  • Dow 30

    35,061.55
    +238.15 (+0.68%)
     
  • Nasdaq

    14,836.99
    +152.39 (+1.04%)
     
  • Russell 2000

    2,209.65
    +10.17 (+0.46%)
     
  • Crude Oil

    72.17
    +0.10 (+0.14%)
     
  • Gold

    1,802.10
    +0.30 (+0.02%)
     
  • Silver

    25.24
    +0.01 (+0.03%)
     
  • EUR/USD

    1.1770
    -0.0003 (-0.0235%)
     
  • 10-Yr Bond

    1.2860
    +0.0210 (+1.66%)
     
  • Vix

    17.20
    -0.49 (-2.77%)
     
  • GBP/USD

    1.3769
    +0.0002 (+0.0138%)
     
  • USD/JPY

    110.4470
    +0.3320 (+0.3015%)
     
  • BTC-USD

    34,406.96
    +559.43 (+1.65%)
     
  • CMC Crypto 200

    786.33
    -7.40 (-0.93%)
     
  • FTSE 100

    7,027.58
    +59.28 (+0.85%)
     
  • Nikkei 225

    27,548.00
    +159.80 (+0.58%)
     

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

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

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. 

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.