Pair of Covid-19 Drugs Performed Well in Studies, Makers Say
2021年3月30日 - 1:50AM
Dow Jones News
By Joseph Walker
A pair of experimental Covid-19 treatments produced positive
results in clinical trials, the companies developing the drugs said
Monday.
Humanigen Inc. said hospitalized patients receiving its drug
lenzilumab had a 54% greater likelihood of surviving without the
need for mechanical ventilation with a breathing tube after one
month than a comparison group that received placebos in a
late-stage, or Phase 3, study.
Separately, a midstage study of healthier patients with mild to
moderate symptoms showed encouraging results for a cocktail of
monoclonal antibody drugs from Eli Lilly & Co. and partners Vir
Biotechnology Inc. and GlaxoSmithKline PLC.
Humanigen, based in Burlingame, Calif., said it would use the
data to seek the drug's authorization from the U.S. Food and Drug
Administration as soon as possible.
Its drug is intended to reduce inflammation experienced by some
Covid-19 patients that is thought to occur as a result of an
overactive immune response to the new coronavirus.
The study didn't prove the drug reduces deaths, however. Among
patients receiving lenzilumab, the death rate was 9.6%, compared
with 13.9% in the placebo group. The difference wasn't
statistically significant, though the company said the study wasn't
designed primarily to demonstrate a reduction in deaths.
Shares of Humanigen rose more than 90% on Monday; the stock has
quadrupled in the past 12 months.
The drug was studied in combination with other treatments
including remdesivir, an antiviral, and dexamethasone, an
anti-inflammatory steroid.
Humanigen is one of many companies and academic groups
researching drugs targeting the immune system to help treat severe
inflammation, sometimes called "cytokine storm," caused by
Covid-19.
The steroid dexamethasone reduced deaths by a third in a study
conducted by U.K. researchers last summer and is thought to work by
broadly blunting the immune system. The drug is now a standard
treatment for most hospitalized patients.
The same U.K. scientists recently reported that the rheumatoid
arthritis drug tocilizumab reduced deaths by 20%. The drug blocks
an immune-system protein called Interleukin-6. Tocilizumab is sold
in the U.S. under the brand name Actemra by Genentech, a subsidiary
of Roche Holding AG.
The cocktail under development by Glaxo, Lilly and Vir reduced
virus levels by 70% compared with a placebo after one week in a
study of about 200 younger, relatively healthy patients with mild
to moderate Covid-19 symptoms who are at low-risk of developing
severe disease. Virus levels were measured using nasal swabs.
The study evaluated Lilly's bamlanivimab, the first antibody
drug authorized for Covid-19, and Vir and Glaxos's VIR-7831, which
recently showed strong results in treating high-risk patients.
No patients in the Phase 2 study were hospitalized or died
regardless of whether they received the drug cocktail or a placebo,
which could raise questions of how much utility antibody drugs will
have in lower-risk patients if most of them are likely to recover
on their own.
One study patient who received the drug cocktail visited an
emergency room for Covid-19 related symptoms, the companies
said.
The companies didn't say whether they would advance the cocktail
into a Phase 3 study to show it prevents hospitalizations. A Glaxo
spokeswoman said the companies are in discussions about any future
trials.
Monoclonal antibody drugs are designed to mimic the function of
natural antibodies produced by the immune system to fight the
coronavirus. So far, they are only authorized to treat patients who
because of age or other illnesses are at high risk of developing
severe cases of Covid-19 that could result in hospitalization or
death.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
March 29, 2021 12:35 ET (16:35 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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