Vir Biotechnology and GlaxoSmithKline (GSK) have reported that an independent Data and Safety Monitoring Board (DSMB) has recommended halting enrolment in the VIR-7831 (GSK4182136) arm of the Phase III ACTIV-3 clinical trial while the data matured.
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody that is designed to achieve high concentration in the lungs to guarantee optimal penetration into airway tissues affected by SARS-CoV-2.
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The trial is part of the US National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) programme.
The latest recommendation is based on a routine, pre-planned safety and efficacy data review conducted on 300 hospitalised Covid-19 patients who are part of ACTIV-3.
While VIR-7831 met initial pre-specified criteria to progress into the next phase of the ACTIV-3 trial, sensitivity analyses of the available data raised doubts on the potential benefit of the antibody.
No reported safety signals were observed in the trial.
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By GlobalDataThe companies will continue to hold talks with the NIH on the course of action to further analyse VIR-7831’s potential in hospitalised Covid-19 patients, while all parties get a complete understanding of the emerging data.
Vir Biotechnology CEO George Scangos said: “While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients.
“In addition, we are eagerly anticipating the upcoming data from the Phase III COMET-ICE trial in newly-diagnosed Covid-19 patients at high risk of hospitalisation.”
Apart from this trial, VIR-7831 is being analysed in the outpatient setting in the Phase III COMET-ICE trial and Phase II BLAZE-4 trial.
Last month, GSK decided to amend a Covid-19 study that seeks to determine the effectiveness of a fully human monoclonal antibody, Otilimab, in treating hospitalised adult patients with Covid-19.
