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Phase III IM administration data for sotrovimab
Phase III IM administration data for sotrovimab.
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[{"type":"text","content":"\n \n \n \n RNS Number : 2554S\n GlaxoSmithKline PLC\n 12 November 2021\n \n \n \n \n Issued: 12 November 2021, London UK and San Francisco, U.S. \n \n \n \n \n \n Primary endpoint met in COMET-TAIL Phase III trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19\n \n \n \n \n \n ·\n COMET-TAIL Phase III data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations\n \n \n · \n The trial enrolled participants during the Delta variant wave of the pandemic in the US\n \n \n \n \n \n \n \n \n \n GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Vir) (Nasdaq: VIR) \n \n today announced headline data from the randomised, multi-centre, open-label COMET-TAIL Phase III trial, which achieved its primary endpoint, demonstrating intramuscular (IM) administration of sotrovimab was non-inferior to intravenous (IV) administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalised adults and adolescents (12 years of age and older).\n \n \n The COMET-TAIL Phase III trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset. In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalisation for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg). The adjusted difference between the IM and IV arms of the trial was 1.07% with a 95% confidence interval (CI) of -1.25% to 3.39%. The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial's primary endpoint in consultation with the US Food and Drug Administration (FDA).\n \n \n In addition, there were low rates of serious adverse events and Grade 3-4 adverse events (≤1% in both arms, for both measures) observed in the headline data.\n \n \n The companies plan to progress regulatory submissions globally, including ongoing discussions with the FDA regarding the existing Emergency Use Authorization for sotrovimab.\n \n \n \n Dr Hal Barron, Chief Scientific Officer and President, said:\n \n \"I am pl...