- Vir Biotechnology and GlaxoSmithKline will seek emergency clearance of their antibody treatment for early-stage COVID-19 patients after research found it could reduce the risk of hospitalization and death by 85%.
- An independent committee monitoring the COMET-ICE study said no new patients should be enrolled because an interim analysis found a significant difference in outcomes between patients given a placebo and those who received the experimental treatment, VIR-7831.
- The companies said they have also seen evidence, based on test tube studies, that VIR-7831 is effective against new strains of the virus that emerged from the U.K., South Africa and Brazil. Vir shares jumped 28% in early trading Thursday morning after the announcement late Wednesday.
The COMET-ICE results represent the first major success for Vir and GSK after a major setback for their coronavirus treatment just days ago. On March 3, Vir said the National Institutes of Health stopped a study of the drug in hospitalized patients for lack of benefit, sending Vir shares tumbling.
The interim analysis of this study looked at 583 non-hospitalized patients, with half getting placebo and the other half the treatment. In addition to the significant reduction in hospitalizations and deaths among the treatment group, the study found that VIR-7831 was well-tolerated, the companies said.
Importantly, 63% of the participants in the study were Latinx and 7% were Black, communities that have been disproportionately affected by the pandemic. Patients already enrolled in the study will continue to be followed for 24 weeks, and more data will be available later, the companies said.
Vir and GSK said they will ask the Food and Drug Administration to authorize emergency use of VIR-7831 and also use the study as the basis for the standard biologics approval application. The companies said they will be seeking clearances from regulators in other countries as well.
Vaccinations are starting to tame the virus in some countries, but the pandemic is still raging around the world, highlighting the need for effective treatments. More than 2.7 million new COVID-19 cases were reported last week, a 2% increase over the previous week, according to the World Health Organization.
Vir's medicine is similar to available antibody treatments from Regeneron and Eli Lilly & Co., in that it works best when given soon after diagnosis with COVID-19. The Regeneron and Lilly treatments have emergency clearance in the U.S. for high-risk patients who aren’t hospitalized — the same population studied in Vir's trial.
Regeneron's and Lilly's antibody cocktails are designed to better fight mutations by attacking the virus in different ways with two different antibodies. VIR-7831 has only a single antibody, but it targets a part of the virus that is "highly conserved," or more resistant to mutations. Data suggests it can also block the virus from entering cells and clear it from already infected cells, the companies said.
With the fight against emerging variants in mind, Vir and GSK are also teaming up with Lilly to study a combination treatment of VIR-7831 with Lilly's single agent bamlanivimab.