GlaxoSmithKline and partner Vir Biotechnology have seen a key, late-stage test of their experimental COVID-19 drug stopped for new patients amid concerns it may not be working well enough.
In an update Wednesday morning, the two partners said a study of VIR-7831, a dual-action SARS-CoV-2 monoclonal antibody, would see enrollment stopped as an independent data monitoring board said “sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.”
It recommends that the VIR-7831 arm of the trial “be closed to enrollment while the data mature.” The so-called ACTIV-3 program, started in December last year, was part of a new sub-trial with the National Institutes of Health (NIH) assessing the med in hospitalized adults with COVID-19.
GSK and Vir, which partnered up last year and have other tests for the drug still ongoing (which are not affected by this stop), said they “will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data.”
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This heaps more woe onto GSK, which has already been hit by major setbacks in its vaccine and internal drug efforts against COVID-19, and drug R&D against the virus in general, which has seen a number of repurposed drugs as well as experimental efforts from companies like Merck flop or be hit by trouble.
Both companies said safety was not an issue in the 300 dosed patients from the test.
“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,” said Vir CEO George Scangos, Ph.D.
“We want to thank the patients who participated in this study and the NIH for investing in the ACTIV trial to evaluate the four monoclonal antibodies, as it recognizes the need for differentiated treatments, especially as new variants emerge globally,” added Christopher Corsico, M.D., senior vice president of development at GSK.
“These and other anticipated data will provide valuable insights about how VIR-7831 can contribute to the fight against this pandemic.”
Vir’s shares tumbled nearly 30% on the news, while GSK was flat.