Covid-19 Antibody Drug Effective in Study, GlaxoSmithKline and Vir Say
March 10 2021 - 11:04PM
Dow Jones News
By Joseph Walker
A monoclonal-antibody drug reduced hospitalizations or death
from Covid-19 by 85% compared with a placebo in a clinical trial,
said Vir Biotechnology Inc. and GlaxoSmithKline PLC, the drug's
developers.
Based on the positive results, the companies said Wednesday they
will immediately ask health regulators in the U.S. and other
countries to authorize the therapy, which would add to the arsenal
of Covid-19 treatments that help keep infected people out of
hospitals.
If authorized, the medicine would be the fourth antibody drug
available in the U.S. after ones made by Eli Lilly & Co. and
Regeneron Pharmaceuticals Inc. Then-President Donald Trump praised
Regeneron's for his recovery, but the drugs have been lightly
used.
Vir and Glaxo said that an independent monitoring committee
recommended the study be stopped early because an interim analysis
of data from 583 study subjects showed the drug, called VIR-7831,
was highly effective.
"We look forward to the possibility of making VIR-7831 available
to patients as soon as possible and to further exploring its
potential in other settings," said Hal Barron, Glaxo's chief
scientific officer and president of research and development.
The companies didn't disclose detailed study results, such as
the percentage of patients who were hospitalized or died.
Study volunteers will continue to be monitored for 24 weeks, and
more data will be released after the study is completed, the
companies said. The study is evaluating patients with mild or
moderate Covid-19 symptoms who are at a high risk of developing
severe disease.
Monoclonal antibodies are the only treatments authorized for
patients early in the course of disease who are at high risk of
becoming hospitalized. However, many of the available doses have
gone unused because of the logistical challenges the drugs present
for hospitals, such as finding space and staff to oversee the
infusions.
Some patients have said it is difficult to find treatment sites
to receive the drugs. In response, HHS, Eli Lilly and Regeneron
have sponsored online infusion-site locator tools.
Nationwide, 34% of the doses allocated to states are
administered to patients, a spokeswoman for the Department of
Health and Human Services said last week.
Vir and Glaxo said a separate study of VIR-7831 showed it
remains effective against new coronavirus variants identified in
the U.K., South Africa and Brazil that scientists worry could prove
resistant to monoclonal antibody drugs.
A scientific paper detailing the variant study results will be
published online on a so-called preprint server, the companies
said. Preprint servers are used to disseminate research findings
before they are published in peer-reviewed journals.
"These findings, paired with our pending publication of
resistance data, demonstrate the potential of VIR-7831 to prevent
the most severe consequences of Covid-19 and highlight its
potential ability to protect against the current circulating
strains of the virus," said Vir Chief Executive George Scangos.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
March 10, 2021 22:49 ET (03:49 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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