17th Dec 2020 21:45
(Alliance News) - GlaxoSmithKline PLC and Vir Biotechnology Inc said Thursday they have started the US National Institutes of Health sponsored ACTIV-3 trial for evaluating VIR-7831 in hospitalised adults with Covid-19.
The pair said that the first patient has been dosed in a new sub-trial of the NIH's Accelerating Covid-19 Therapeutic Interventions & Vaccines Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalised adults with COVID-19.
VIR-7831, also known as GSK4182136, is a fully human anti-SARS-CoV-2 investigational monoclonal antibody to treat the virus.
The ACTIV-3 trial will initially compare 300 participants who have been hospitalised with mild to moderate Covid-19 with fewer than 13 days of symptoms, who will receive either VIR-7831 or the placebo.
Participants also will receive standard care for Covid-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants' clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care, the companies said.
If the VIR-7831 treatment arm appears to have a positive benefit, the trial will enrol an additional 700 participants, including those who are more severely ill. Trial participants will be followed for 90 days following enrolment to analyse their response to treatment, the pair added.
The primary efficacy endpoint is the participants' sustained recovery for 14 days after release from hospital.
Glaxo Chief Scientific Officer Hal Barron said: "With new infection and hospitalisation rates reaching record highs, the world needs multiple options to help combat this pandemic. We are developing solutions to fight this virus, from prevention through treatment, to provide relief from COVID-related illness. Our treatment option, VIR-7831, which has a high barrier to resistance and has the potential to neutralise the virus and kill infected cells, could allow this treatment to be effective for patients in hospital settings, where other antibodies have so far not shown an impact."
Glaxo shares closed flat at 1,364.40 pence Thursday.
By Arvind Bhunjun; [email protected]
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