By Kate Kelland
LONDON, Sept 14 (Reuters) - The world's largest randomised
trial of potential medicines for COVID-19 is to add Regeneron's
experimental antiviral antibody cocktail REGN-COV2 to
the drugs it is testing in patients hospitalised with the
The UK RECOVERY trial, which has been testing a range of
potential COVID-19 treatments since it began in April, will
compare the effects of adding REGN-COV2 - a lab-manufactured
monoclonal antibody - to standard care.
"This is the first drug actually designed for this disease,"
said Martin Landray, a professor of medicine & epidemiology at
Oxford University who is co-leading the trial.
"There are lots of good reasons for thinking this might be
really quite a powerful treatment," he told Reuters in an
The addition of Regeneron's drug to the RECOVERY trial comes
amid growing hopes that monoclonal antibodies may emerge as
effective ways to treat COVID-19.
Until now, the RECOVERY trial had mostly been studying
whether existing drugs could be re-purposed to tackle the new
disease, and it has already found answers on a number of them.
In June and September, trial results showed that widely used
steroids such as dexamethasone and hydrocortisone were able to
reduce death rates among severely-ill COVID-19 patients
Also in June, RECOVERY trial results showed that the
anti-malarial drug hydroxychloroquine, once touted by U.S.
President Donald Trump as a potential "game changer" in the
pandemic, was of no benefit in treating COVID-19 patients.
Regeneron's REGN-COV2 cocktail, which the company is already
testing in late-stage clinical trials in people, combines one
Regeneron-made antibody and a second antibody isolated from
people who have recovered after being infected with COVID-19.
The combination is designed to bind to the spike protein
used by the new coronavirus to gain access to human cells,
limiting the virus's ability to escape.
Regeneron developed the biological drug before linking up
with Roche to expand its manufacturing capacity in hopes
of meeting global demand, should the medicine prove effective.
Regeneron would handle U.S. sales, with Roche selling the
medicine around the world.
Landray said his team had secured enough supply of the drug
so that up to "several thousand" patients could be given it in
the trial and compared with several thousand controls.
"Given that the second phase (of COVID-19 infections in the
UK) seems to be coming now, it is a really good time to be
starting this," he said.
The United States already has a $450 million deal for the
cocktail in place, under the terms of which Regeneron will sell
it around 70,000 to 300,000 potential treatment doses or 420,000
to 1.3 million prevention doses of REGN-COV2. Data is due later
this month, Regeneron has said.
Alongside Regeneron, Eli Lilly, working with biotech
firm AbCellera, is seen as a leading contender in the antibody
race. In August it started testing whether its antibody can
prevent COVID-19 infections in nursing homes. A separate trial
testing the compound on recently diagnosed COVID patients may
yield initial data in September or shortly after.
GlaxoSmithKline and partner Vir Biotechnology
also began testing an experimental antibody on newly
diagnosed COVID-19 patients late last month.
AstraZeneca is for now testing its antibody-based
cocktail on healthy volunteers for tolerability.
(Reporting by Kate Kelland, additional reporting by Deena
Beasley, John Miller and Ludwig Burger; editing by Susan Fenton)