GlaxoSmithKline Plc and Vir Biotechnology Inc. said their Covid-19 antibody therapy showed a significant reduction of hospitalization and death for at-risk patients in an advanced-stage trial that progressed faster than expected.
The companies said Thursday that they will immediately seek emergency-use authorization in the U.S. after they finished a late-stage study early on the recommendation of an independent monitoring board. The treatment, VIR-7831, reduced the numbers of patients who were hospitalized or died by 85% compared to a placebo, the companies said.
Vir Biotechnology shares rose 41% in pre-market trading.
The trial was focused on the early treatment of non-hospitalized Covid-19 patients at high risk of being admitted and is one of a number Glaxo and Vir are conducting using this monoclonal antibody. Enrollment in another study looking at the effects of VIR-7831 in hospitalized patients was stopped last week after the data raised concerns about the potential benefit.
Monoclonal antibodies may play a key role in protecting people less responsive to vaccines or unable to be inoculated against SARS-CoV-2 such as cancer patients who have more suppressed immune systems. Antibody treatments from Eli Lilly and Co. and Regeneron Pharmaceuticals Inc. both received emergency-use authorizations from the U.S. in November. As the third antibody treatment to show success, Glaxo and Vir may have limited sales potential this year, according to Bloomberg Intelligence analyst Sam Fazeli.
Glaxo has faced a number of setbacks in its approach to tackling Covid-19. The British pharmaceutical giant opted to partner with a number of companies using its adjuvant technology in the creation of a vaccine. A tie-up with Sanofi has faced delays after a dosing error last year, while a partnership with Sichuan Clover Biopharmaceuticals Inc. ended.
Last month, the company agreed to work with CureVac NV to help boost production of the German company’s experimental vaccine and improve the shot to help protect against multiple variants.
Glaxo and Vir also presented data Thursday showing the antibody therapy is active against variants that have originated in the U.K., South Africa and Brazil. The companies are also examining different methods of delivering the antibody and are set to begin another trial in the second quarter looking at whether the drug can prevent Covid-19 in uninfected high-risk adults.