The therapy, REGEN-COV, has been granted emergency use authorisation
for people with mild-to-moderate COVID-19 in the United States, but
results from the RECOVERY trial provide the clearest evidence of its
effectiveness among hospitalised patients.
It found that the antibody therapy reduced by a fifth the 28-day
mortality of people admitted to hospital with COVID-19 whose immune
system had not mounted an antibody response, known as seronegative.
The result translates into six fewer deaths for every 100
seronegative patients treated with the therapy, researchers said.
There was no discernible effect of the treatment on those who had
generated natural antibody responses and were seropositive.
"People have been very, very sceptical, that any treatment against
this particular virus would work by the time people get in
hospital," Martin Landray, the joint chief investigator on the
trial, told reporters.
"If you haven't raised antibodies of your own, you really would
benefit from getting some," he said.
The treatment also shortened the hospital stay of those who were
seronegative and reduced their chances of needing a mechanical
ventilator, Landray said.
Regeneron had previously said its treatment had shown enough promise
in hospitalised patients to warrant continuing its trial. This data
provides the first large-scale confirmation of that assertion.
There were 9,785 patients hospitalised with COVID-19 who were
randomly allocated to receive usual care plus the antibody
combination therapy or just usual care, of which 30% were
seronegative.
The RECOVERY trial also showed the steroid dexamethasone and Roche's
arthritis drug Actemra (tocilizumab) cut deaths in hospitalised
patients.
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While those treatments focus on
inflammation caused by reaction to the
coronavirus, Regeneron's therapy, which belongs
to a class of biotech drugs called monoclonal
antibodies, mimic natural antibodies the body
produces to fight off the infection.
"This is the first time we've got one that's actually targeting the
virus itself," Landray said, adding that it could be used along with
the other treatments.
"It's not that you do one thing or another thing. These benefits are
additive in these patients," he said.
POSSIBILITY FOR OTHERS
Other companies have been developing similar treatments.
U.S. emergency use authorization has been granted to antibody
treatments developed by Eli Lilly and Co as well as by Vir
Biotechnology Inc with GlaxoSmithKline Plc. Both are approved for
use in mild-to-moderate cases. On Tuesday,
AstraZeneca said its antibody therapy had shown no evidence of
protecting people from developing the disease following exposure,
although other trials of its cocktail as a prevention or a treatment
are ongoing.
Landray said the RECOVERY results should give developers of other
monoclonal antibody therapies optimism that they can also be used in
some hospitalised patients.
"This opens up the possibility for many, many others," he said.
"People see a few negative trials and they say 'well that'll never
work' and they opt out and go off and do something else. (But) this
is very, very clear, the picture that we've got from this trial."
(Reporting by Alistair Smout; Editing by Bill Berkrot)
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