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(Alliance News) - GlaxoSmithKline PLC and Vir Biotechnology Inc on Tuesday said a study of candidate VIR-7831 as a treatment for Covid-19 has been expanded into phase 3.
At the end of September, the independent data monitoring committee recommended continuing the Comet-Ice study into phase 3 based on positive safety and tolerability data from phase 2.
The phase 3 study will evaluate VIR-7831, also known as GSK4182136, as an early treatment for Covid-19 in patients at high risk of hospitalisation. VIR-7831 is a monoclinal antibody selected on its potential ability to neutralised the virus, kill infected cells, and provide a barrier to resistance. It also has potential to achieve high concentration in the lungs, which its the major site of infection in Covid-19.
Initial phase 3 results could be available as soon as 2020 end, and results for the primary endpoint of the study are due in the first 2021 quarter, with the current estimate being January 2021.
The primary endpoint is the proportion of patients with progression of Covid-19 as defined
by the need for hospitalisation or death within 29 days of randomisation.
This study will assess safety and efficacy of a single dose of VIR-7831 or placebo in approximately 1,300 non-hospitalised participants globally, 670 in the treatment arm and 670 in the placebo arm.
Glaxo and Vir said that, if it proves successful in trials, "VIR-7831 has the potential to advance outpatient treatment for Covid-19".
The Comet clinical development programme for VIR-7831 includes two further trials, one in hospitalised patients and another for the prevention of symptomatic infection.
Vir and Glaxo also plan to start their phase 1b/2a trial in late 2020 evaluating VIR-7832. VIR-7832 is a second investigational SARS-CoV-2 neutralising antibody and shares the same characteristics as VIR-783 with the addition of enhanced effector function.
Hal Barron, chief scientific officer and president R&D at Glaxo, said: "Given the urgent patient need I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a phase 3 trial in only six months since announcing our collaboration with Vir. We believe this neutralising antibody's high barrier to resistance, notable effector function, and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic."
Shares in Galxo were down 1.0% at 1,435.31 pence in London on Tuesday afternoon.
By Anna Farley; annafarley@alliancenews.com
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