The trial has an "adaptive" design and could quickly move from
dozens of patients to eventually include thousands, Chief Scientific
Officer George Yancopoulos told Reuters.
"If it goes perfectly well, within a week or two we will move to the
second phase. Within a month or so of that we will have clear data
that this is or isn't working. By the end of summer, we could have
sufficient data for broad utilization."
The dual antibody, called REGN-COV2, is being compared to a placebo
treatment in hospitalized COVID-19 patients, and in COVID-19
patients who have symptoms but are not sick enough to be
hospitalized. Regeneron also plans to study REGN-COV2 for preventing
the infection in people at high-risk of exposure - such as
healthcare workers - and in uninfected people with close exposure to
someone who has tested positive for the virus.
Antibodies are proteins made by the body's immune system that
recognize, bind and neutralize an invading virus. Regeneron's
cocktail - which contains an antibody made by the company and a
second isolated from humans who recovered from COVID-19 - is
designed so that its two antibodies bind to the coronavirus' spike
protein, limiting the ability of viruses to escape.
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Trial patients will be given a single intravenous infusion of REGN-COV2. In the
prevention segments of the study, participants will be given smaller
subcutaneous doses, Yancopoulus said. Investigators will be measuring patients'
viral loads and keeping track of symptoms.
Regeneron said its treatment could be useful even if a COVID-19 vaccine is
developed since the elderly and people with compromised immune systems often do
not respond well to vaccines.
Yancopoulos said, even though Regeneron does not yet have proof that REGN-COV2
is effective, the company has cleared the way for production of the antibody
compound at its New York manufacturing facility.
(Reporting by Deena Beasley; Editing by Christopher Cushing)
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