Regeneron Drug Found to Help Treat Covid-19 in Early Disease Stage -- Update
30 September 2020 - 9:57AM
Dow Jones News
By Joseph Walker
Regeneron Pharmaceuticals Inc.'s experimental Covid-19 drug
helped reduce virus levels and improve symptoms in sick patients
who weren't hospitalized, the company said, advancing development
of a medication that could be among the first to treat early-stage
illness from the new coronavirus.
The preliminary results from the company's clinical trial could
support an emergency use authorization, or EUA, from U.S.
regulators, said George D. Yancopoulos, Regeneron president and
chief scientific officer, on a conference call with analysts on
Tuesday. That may allow the drug to be prescribed before clinical
trials are completed showing it is safe and effective.
"The totality of the data and the way it all hangs together
really suggests we're impacting viral load," Dr. Yancopoulos said
on the call. "It's up to regulators and society to decide" whether
and when to make it available more widely to patients, he said. One
possibility is that regulators ask the company to confirm the
results with an analysis of patients that it has subsequently
enrolled in the trial, he added.
Regeneron's drug, code-named REGN-COV2, is part of a class of
medicines known as monoclonal antibodies that are designed in labs
to mimic the naturally occurring antibodies that the immune system
produces to fight off viruses and other foreign invaders. A rival
antibody drug in development by Eli Lilly & Co. recently showed
encouraging but mixed results in a Phase 2 trial of nonhospitalized
patients.
So far, only a few drugs have been shown to work against
Covid-19 and only in hospitalized patients. Regeneron is among a
number of companies racing to develop effective treatments that can
be used before patients become severely ill.
Shares of Regeneron rose 2% in after-hours trading; the stock is
up more than 50% so far this year, largely on high expectations for
the antibody drug.
The company's Covid-19 drug was most effective in treating
patients who hadn't yet developed an effective immune response,
which researchers measured by testing patients for antiviral
antibodies before beginning treatment, and in patients with high
virus levels in their respiratory systems.
The median number of days it took to alleviate symptoms in
patients without antibodies was eight days among those who received
the highest dose of the drug, six days in those who received the
lowest dose, and 13 days in patients who were given placebos,
Regeneron said.
In patients without coronavirus antibodies, the reduction in
viral load across both doses of Regeneron's drug, compared with
placebo, would have been statistically significant if it were a
preplanned analysis, the company said.
The study data showed that patients who have low levels of
virus, or who have already mounted an immune antibody response, are
unlikely to benefit from the drug, Dr. Yancopoulos said in an
interview. "If you're mounting an immune response, you're wiping
out the virus," he said.
"The greatest treatment benefit was in patients who had not
mounted their own effective immune response, suggesting that
REGN-COV2 could provide a therapeutic substitute for the
naturally-occurring immune response," Dr. Yancopoulos said in a
statement. "These patients were less likely to clear the virus on
their own, and were at greater risk for prolonged symptoms."
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
September 29, 2020 19:42 ET (23:42 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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