Vir, Glaxo: Data Safety Board Recommends VIR-7831 Arm of NIH Trial Be Closed to Enrollment
March 03 2021 - 10:14AM
Dow Jones News
By Michael Dabaie
Vir Biotechnology Inc. and GlaxoSmithKline PLC said Wednesday
the independent data and safety monitoring board recommended the
VIR-7831 arm of the National Institutes of Health's Accelerating
Covid-19 Therapeutic Interventions and Vaccines Program Phase 3
clinical trial be closed to enrollment.
Vir shares were down 31%, to $40, in early trading.
The companies said they were informed that while VIR-7831 met
initial pre-specified criteria to continue to the next phase of the
ACTIV-3 trial and there were no reported safety signals,
sensitivity analyses of the available data raised concerns about
the magnitude of potential benefit.
The monitoring board recommended the VIR-7831 arm of the trial
be closed to enrollment while the data mature, the companies
said.
The companies said they would 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.
The DSMB recommendation was based on a routine, pre-planned
safety and efficacy data review of the first 300 patients
hospitalized with Covid-19 enrolled in ACTIV-3.
"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 Chief Executive
George Scangos.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 03, 2021 09:59 ET (14:59 GMT)
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