By Joseph Walker
A kind of drug that takes a page from a body's natural antibody
defenses may be able to give many people early protection against
the coronavirus, ahead of vaccines.
Few treatments so far have been shown to be effective against
Covid-19, and even then, only in hospitalized patients. Potential
vaccines, meanwhile, are probably months away from completing
testing and becoming available to the general public.
Researchers and health officials express hope certain drugs,
known as monoclonal antibodies and in testing by companies
including Regeneron Pharmaceuticals Inc. and Eli Lilly & Co.,
will fill the breach.
"There is a need for safe therapies to be given early in disease
and monoclonal antibodies are paramount among them," said National
Institute of Allergy and Infectious Diseases Director Anthony
Fauci. "I'm very anxious to see what the results are."
The drugs, which are injected intravenously or with a short
needle, have the potential to work soon after someone is infected
and still feeling only slightly sick, stopping the virus in its
tracks before the seriously afflicted would need to be
hospitalized.
The monoclonal antibodies might also prevent infection in
healthy people, though likely only for about a month. If the
promise bears out during testing, the drugs could stand in as a
type of temporary vaccine for people at high risk of infection,
such as nursing-home residents and possibly health-care
workers.
"Today if you get Covid, you will have a wave of fear of
biblical proportions," said Myron Cohen, an infectious-disease
specialist at the University of North Carolina who is overseeing
antibody studies for the NIAID.
"If I can give you a shot and guarantee you I stop the
progression of disease, the world changes," he added.
Among the companies planning to launch antibody studies in
people this year are Vir Biotechnology Inc. and partner
GlaxoSmithKline PLC, and privately held Adagio Therapeutics Inc.
AstraZeneca PLC this month launched a Phase 1 study of an antibody
drug it licensed from Vanderbilt University.
Covid-19 clinical trials are now under way for 10 new monoclonal
antibodies, known as mAbs in industry jargon, according to the
Antibody Society, a professional association of researchers.
The most advanced are already in mid- and late-stage studies in
newly diagnosed as well as hospitalized patients, and in people who
haven't yet been infected. If they clear testing, the drugs might
be available as soon as early in the fourth quarter, according to
Geoffrey Porges, an SVB Leerink LLC analyst.
Early signs are preliminary but positive. Regeneron's antibody
drug both cleared and prevented coronavirus infections in a study
in monkeys and hamsters.
Another reason for optimism, infectious disease experts say, is
that the antibody drugs developed by Regeneron and the National
Institutes of Health were shown to be effective in the Ebola
virus.
Yet some researchers who expect antibody drugs to work in
clinical trials are skeptical how much real-world impact they would
then have.
Doctors may be reluctant to prescribe a brand-new, expensive
medication to patients early on in their disease when the drug is
most likely to be effective, said Florian Krammer, a microbiologist
at the Icahn School of Medicine at Mount Sinai in New York.
"The problem is putting it into practice and when are you going
to use them?" said Dr. Krammer. "Are you going to give it to
someone who comes in who's only a little symptomatic? Probably
not."
The drugs would likely be used preventively by those at high
risk of infection or severe complications from the disease, such as
nursing-home residents and workers, or people exposed to a
household member who tested positive for the virus.
Regeneron and Eli Lilly say that even if the drugs work, there
won't be enough to treat everyone because there aren't enough
manufacturing plants able to do the high-tech manufacturing that
mAbs require.
Finite supplies will mean that government officials, nonprofit
organizations and drugmakers will likely have to come together to
set guidelines for who gets the drugs, said Eli Lilly Chief
Scientific Officer Dan Skovronsky.
"It's not a question of cost or working harder or a desire to
make it. It's just the simple math, the number of manufacturing
facilities in the world that are available," he said. "And we can't
stop making cancer drugs or insulin or anything like that."
Regeneron joined with rival Roche Holding AG this past week to
more than triple the manufacturing capacity for its drug, but said
the increase probably still won't be enough to meet demand.
Monoclonal antibodies are human-made cells that latch onto
proteins that drive disease.
Their discovery in the 1970s helped give birth to the modern
biotechnology industry, and they have been turned into blockbuster
treatments for cancer, vision loss and chronic inflammatory
diseases.
Doctors and health officials are looking to the drugs to fill a
big gap in Covid-19 treatment. The only drugs shown to be effective
against the disease are for sick patients well along the course of
the disease, not for patients in the early stages of infection.
Vaccines promise to protect people against infection, or at
least reduce the severity of a case. The most advanced are just
starting late-stage testing. And if they pass muster, there
probably won't be enough initial supplies for many people.
Regeneron and Lilly executives say the complexities of
conducting studies during the pandemic make it difficult to
confidently predict when they will have firm answers on which
patients respond best to their drugs, if at all.
To quickly enroll patients, the companies have had to predict
virus hot spots ahead of time and then work with overworked doctors
who may be too overwhelmed to always focus on clinical trials.
"We're a little bit like storm chasers, but we're pandemic
chasers," said Regeneron Chief Executive Leonard Schleifer.
Delays getting coronavirus test results for potential study
subjects are also complicating enrollment. The delays, of as much
as 10 days, wind up disqualifying some patients from studies that
require them to be enrolled within three or four days of testing
positive.
"If you can't test people rapidly, that precludes being able to
do a study in recently diagnosed people," said Lilly's Dr.
Skovronsky. "Improved diagnostics is part of the answer to improved
therapeutics."
In August, late-stage studies were launched evaluating Lilly's
lead antibody in hospitalized and nonhospitalized patients, and
these could be completed before the end of the year, depending on
how quickly patients are enrolled.
Regeneron expects to have the first data from its study of a
monoclonal antibody in hospitalized and nonhospitalized patients by
the end of September. The company could seek an emergency
authorization based on the data if there is a strong indication the
drug is blocking the virus.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
August 23, 2020 05:44 ET (09:44 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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