TARRYTOWN, N.Y. and
OXFORD, England, Sept. 14, 2020
/PRNewswire/ --
One of the world's largest efforts to find effective COVID-19
treatments will evaluate the impact of REGN-COV2 on mortality,
hospital stays, and the need for ventilation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and the
University of Oxford today announced
that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of
the world's largest randomized clinical trials of potential
COVID-19 treatments, will evaluate Regeneron's investigational
anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label
trial in patients hospitalized with COVID-19 will compare the
effects of adding REGN-COV2 to the usual standard-of-care versus
standard-of-care on its own.
Peter Horby, Professor of
Emerging Infectious Diseases and Global Health, Nuffield Department
of Medicine, University of Oxford and
chief investigator of the trial, said "We have already discovered
that one treatment, dexamethasone, benefits COVID-19 patients, but
the death rate remains too high so we must keep searching for
others. The RECOVERY trial was specifically designed so that when
promising investigational drugs such as REGN-COV2 became available
they can be tested quickly. We are looking forward to seeing
whether REGN-COV2 is safe and effective in the context of a
large-scale randomized clinical trial; this is the only way to be
certain about whether it works as a treatment for COVID-19."
"The world urgently needs new medicines to combat COVID-19, and
well-designed trials to evaluate new treatment options will quickly
help us learn which are most effective," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "REGN-COV2 was
specifically designed by Regeneron scientists to target the virus
that causes COVID-19. RECOVERY will be the fourth late-stage
randomized clinical trial evaluating REGN-COV2 and will add to our
knowledge about how this novel antibody cocktail may help
hospitalized patients in need."
REGN-COV2 is the first specifically designed COVID-19 therapy
being evaluated by RECOVERY. It was selected in part based on its
emerging safety profile in humans, pre-clinical data showing it
could protect against viral escape mutations, and prevention and
treatment studies in non-human primates showing it reduced the
amount of virus and associated damage in the lungs. REGN-COV2 is
currently being studied in two Phase 2/3 clinical trials for the
treatment of COVID-19 and in a Phase 3 trial for the prevention of
COVID-19 in household contacts of infected individuals.
Martin Landray, Professor of
Medicine & Epidemiology, Nuffield Department of Population
Health, University of Oxford, added,
"Throughout the COVID-19 pandemic we have seen the power of
randomized trials to provide rigorous assessment of potential
treatments. Up to now, we have largely been studying whether
existing drugs can be re-purposed to tackle this new disease, but
we now have the opportunity to rigorously assess the impact of a
drug specifically designed to target this coronavirus. There are
good reasons to be excited about this new development – RECOVERY
will provide a robust assessment of the effect of this
lab-manufactured monoclonal antibody combination treatment in
hospitalized patients.
"We are very grateful to the patients who have already taken
part in the trial and to those who will participate in this next
phase of RECOVERY. We would not be able to find the best treatments
without their support and that of the thousands of hospital and
research staff who are working with us."
The open-label RECOVERY trial will assess the impact of adding
REGN-COV2 to the usual standard-of-care on all-cause mortality 28
days after randomization. Other endpoints include the impact on
hospital stay and the need for ventilation. It is anticipated that
at least 2,000 patients will be randomly allocated to receive
REGN-COV2 plus usual standard-of-care, and results will be compared
with at least 2,000 patients who receive standard-of-care on its
own. Usual standard-of-care varies by local hospital.
The trial is being coordinated by researchers at the
University of Oxford, which acts as the
sponsor for the research, working with clinical teams at 176
hospital sites across the UK.
About the Trial
The RECOVERY trial is conducted by
the registered clinical trials units in the Nuffield Department of
Population Health in partnership with the Nuffield Department of
Medicine. The trial is supported by a grant to the University of
Oxford from UK Research and Innovation/National Institute for
Health Research (NIHR) and by core funding
provided by NIHR Oxford Biomedical Research
Centre, Wellcome, the Bill and Melinda Gates
Foundation, the Department for International Development, Health
Data Research UK, the Medical Research Council Population Health
Research Unit and NIHR Clinical Trials Unit Support
Funding.
The trial involves many thousands of doctors, nurses,
pharmacists, and research administrators at 176 hospitals across
the whole of the UK, supported by staff at the NIHR Clinical
Research Network, NHS DigiTrials, Public Health England, Department
of Health & Social Care, the Intensive Care National Audit
& Research Centre, Public Health Scotland, the Secure
Anonymised Information Linkage at University of Swansea, and the NHS in England, Scotland, Wales and Northern Ireland.
The inclusion of convalescent plasma in the RECOVERY trial was
announced in June. The trial will compare adding convalescent
plasma (plasma taken from patients who have recovered from
COVID-19) to usual standard-of-care versus standard-of-care on its
own.
About REGN-COV2
REGN-COV2 comprises two monoclonal
antibodies (REGN10933 and REGN10987) and was designed specifically
by Regeneron scientists to block infectivity of SARS-CoV-2, the
virus that causes COVID-19. They evaluated thousands of
fully-human antibodies produced by the company's
VelocImmune® mice, which have been genetically
modified to have a human immune system, as well as antibodies
identified from humans who have recovered from COVID-19. The two
potent, virus-neutralizing antibodies that form REGN-COV2 bind
non-competitively to the critical receptor binding domain of the
virus's spike protein, which diminishes the ability of mutant
viruses to escape treatment and protects against spike variants
that have arisen in the human population, as detailed in
Science.
An Independent Data Monitoring Committee is monitoring all
Regeneron-led REGN-COV2 Phase 2 and 3 trials, and all trials
continue to enroll patients.
REGN-COV2's development and manufacturing has been funded in
part by the Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response at the U.S. Department of Health and
Human Services under OT number: HHSO100201700020C. Regeneron has
recently partnered with Roche to increase the global supply of
REGN-COV2. If REGN-COV2 proves safe and effective in clinical
trials and regulatory approvals are granted, Regeneron will
manufacture and distribute it in the U.S. and Roche will develop,
manufacture and distribute it outside the U.S.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune®, which uses
unique genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron
Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual
events or results may differ materially from these forward-looking
statements. Words such as "anticipate," "expect," "intend," "plan,"
"believe," "seek," "estimate," variations of such words, and
similar expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these
risks and uncertainties include, among others, the impact of
SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on
Regeneron's business and its employees, collaborators, and
suppliers and other third parties on which Regeneron relies,
Regeneron's and its collaborators' ability to continue to conduct
research and clinical programs (including those discussed in this
press release), Regeneron's ability to manage its supply chain, net
product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and product
candidates and research and clinical programs now underway or
planned, including without limitation REGN-COV2 (Regeneron's
investigational two-antibody cocktail for the treatment and
prevention of COVID-19); the likelihood, timing, and scope of
possible regulatory approval and commercial launch of Regeneron's
product candidates (such as REGN-COV2) and new indications for
Regeneron's Products; safety issues resulting from the
administration of Regeneron's Products and product candidates (such
as REGN-COV2) in patients, including serious complications or side
effects in connection with the use of Regeneron's Products and
product candidates in clinical trials; uncertainty of market
acceptance and commercial success of Regeneron's Products and
product candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary), including
the RECOVERY trial discussed in this press release, on any
potential regulatory approval and/or the commercial success of
Regeneron's Products and product candidates; determinations by
regulatory and administrative governmental authorities which may
delay or restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and product candidates,
including without limitation REGN-COV2; ongoing regulatory
obligations and oversight impacting Regeneron's Products, research
and clinical programs, and business, including those relating to
patient privacy; the availability and extent of reimbursement of
Regeneron's Products from third-party payers, including private
payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron's Products and product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may be replicated in other
studies and/or lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's Products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license or
collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), as well as
Regeneron's collaboration with Roche discussed in this press
release, to be cancelled or terminated without any product success;
and risks associated with intellectual property of other parties
and pending or future litigation relating thereto (including
without limitation the patent litigation and other related
proceedings relating to EYLEA® (aflibercept)
Injection, Dupixent® (dupilumab), and
Praluent® (alirocumab)), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations, the ultimate outcome of any such proceedings
and investigations, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the U.S.
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2019 and its Form 10-Q for the
quarterly period ended June 30, 2020. Any forward-looking
statements are made based on management's current beliefs and
judgment, and the reader is cautioned not to rely on any
forward-looking statements made by Regeneron. Regeneron does
not undertake any obligation to update publicly any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website
(http://newsroom.regeneron.com) and its
Twitter feed
(http://twitter.com/regeneron).
Contacts:
Media Relations
Alexandra
Bowie
Tel: +1 (914) 847-3407
alexandra.bowie@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
University of
Oxford
Genevieve
Juillet
gen.juillet@admin.ox.ac.uk
University of Oxford - Nuffield
Department of Population Health
Caroline Wood
carolinevenezia3@gmail.com
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SOURCE Regeneron Pharmaceuticals, Inc.