TARRYTOWN, N.Y. and
CAMBRIDGE, Mass., March 16, 2020 /PRNewswire/ --
U.S. Phase 2/3 trial initiated and will begin
enrolling patients immediately
Regeneron is leading U.S. trials, Sanofi will
lead upcoming ex-U.S. trials
Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) and Sanofi today announced they have started a clinical
program evaluating Kevzara® (sarilumab) in patients
hospitalized with severe COVID-19 infection. Kevzara is a
fully-human monoclonal antibody that inhibits the interleukin-6
(IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may
play a role in driving the overactive inflammatory response in the
lungs of patients who are severely or critically ill with COVID-19.
The role of IL-6 is supported by preliminary data from a single-arm
study in China using another IL-6
receptor antibody.
This U.S.-based trial will begin at medical centers in
New York, one of the epicenters of
the U.S. COVID-19 outbreak, and will assess the safety and efficacy
of adding Kevzara to usual supportive care, compared to supportive
care plus placebo. The multi-center, double-blind, Phase 2/3 trial
has an adaptive design with two parts and is anticipated to enroll
up to 400 patients. The first part will recruit patients with
severe COVID-19 infection across approximately 16 U.S. sites, and
will evaluate the impact of Kevzara on fever and patients' need for
supplemental oxygen. The second, larger part of the trial will
evaluate the improvement in longer-term outcomes including
preventing death and reducing the need for mechanical ventilation,
supplemental oxygen and/or hospitalization.
"To initiate this trial quickly, so that the results may inform
evidence-based treatment of this ongoing pandemic, Regeneron and
Sanofi have worked closely with the U.S. Food and Drug
Administration and the Biomedical Advanced Research and Development
Authority, also known as the
FDA and BARDA," said George D.
Yancopoulos, M.D., Ph.D., Co-founder, President and Chief
Scientific Officer of Regeneron. "Data from China suggest that the IL-6 pathway may play
an important role in the overactive inflammatory response in the
lungs of patients with COVID-19. Despite this encouraging
finding, it's imperative to conduct a properly designed, randomized
trial to understand the true impact. Our trial is the first
controlled trial in the U.S. to evaluate the effect of IL-6
inhibition prospectively in COVID-19 patients. In addition to our
Kevzara program, Regeneron is also rapidly advancing a novel
antibody cocktail for the prevention and treatment of COVID-19,
which we hope to have available for human testing this summer. Both
of these programs are made possible by our unprecedented end-to-end
antibody discovery, development and manufacturing technologies,
starting with our proprietary VelocImmune human antibody
mouse, and incorporating our associated rapid manufacturing
technologies designed to select and produce the best neutralizing
antibodies. Collectively, these technologies expedite a typically
years-long process into a matter of months. This same technology
was applied to the Ebola virus, where our therapy, REGN-EB3, was
shown to dramatically improve survival in infected patients last
year."
Scientists have preliminary evidence that IL-6 may play a key
role in driving the inflammatory immune response that causes acute
respiratory distress syndrome (ARDS) in patients critically ill
from COVID-19. Initial non-peer reviewed results from
a single-arm, 21-patient Chinese trial found COVID-19 patients
experienced rapidly reduced fevers and 75% of patients (15 out of
20) reduced their need for supplemental oxygen within days of
receiving a different IL-6 receptor antibody (tocilizumab). Based
on these results, China recently
updated its COVID-19 treatment guidelines and approved the use of
that IL-6 inhibitor to treat patients with severe or critical
disease.
"At Sanofi, we are taking a leading role in addressing the
global challenge of COVID-19 disease. Scientific evidence has emerged to
suggest that Kevzara may be a potentially important
treatment option for critically-ill
COVID-19 patients, and this trial will provide the
well-controlled, rigorous scientific data we need to determine if
IL-6 receptor inhibition with
Kevzara is better than current supportive care alone. Additionally,
we expect to rapidly initiate trials outside the U.S. in the coming
weeks, including areas most affected by the pandemic such as
Italy," said John Reed, M.D.,
Ph.D., Sanofi's Global Head of Research and Development. "In
addition to Kevzara, Sanofi Pasteur, the vaccines global business
unit of Sanofi, is leveraging previous development work for a SARS
vaccine as part of our goal to quickly develop a COVID-19
vaccine."
In late 2019, Regeneron and Sanofi announced their intent to
simplify the joint collaboration for Kevzara, which is expected to
be finalized in the first quarter of 2020. The companies will
continue to collaborate on COVID-19 and other related ARDS
development, with Regeneron leading U.S.-based work and Sanofi
leading work outside of the U.S.
The use of Kevzara to treat the symptoms of COVID-19 is
investigational and has not been fully evaluated by any regulatory
authority.
About the Trial
This Phase 2/3, randomized,
double-blind, placebo-controlled trial uses an adaptive design to
evaluate the safety and efficacy of Kevzara in adults hospitalized
with serious complications from COVID-19. To enter the trial,
patients must be hospitalized with laboratory-confirmed COVID-19
that is classified as severe or critical, or who are suffering from
multi-organ dysfunction. All patients must have pneumonia and
fever. After receiving the study dose, patients will be assessed
for 60 days, or until hospital discharge or death.
In the Phase 2 part of the trial, patients will be randomized
2:2:1 into three groups: Kevzara high dose, Kevzara low dose and
placebo. The primary endpoint is reduction of fever and the
secondary endpoint is decreased need for supplemental oxygen.
The Phase 2 findings will be utilized in an adaptive manner to
determine transition into Phase 3, helping to determine the
endpoints, patient numbers and doses. The second, larger part of
the trial will evaluate the improvement in longer-term outcomes
including preventing death and reducing the need for mechanical
ventilation, supplemental oxygen and/or hospitalization.
If the trial continues with all three treatment arms to the end,
it is expected to enroll approximately 400 patients, depending on
the status of the COVID-19 outbreak and the proportion of patients
with severe COVID-19 and high levels of IL-6.
About Kevzara® (sarilumab)
Injection
Kevzara was jointly developed by Regeneron and
Sanofi under a global collaboration agreement. Kevzara is a
fully-human monoclonal antibody that was invented using Regeneron's
proprietary VelocImmune® technology, which uses a
unique genetically-humanized mouse to produce optimized fully human
antibodies. Kevzara binds specifically to the IL-6 receptor, and
has been shown to inhibit IL-6-mediated signaling. IL-6 is a
signaling protein produced in increased quantities in patients with
rheumatoid arthritis and has been associated with disease activity,
joint destruction and other systemic problems. It is also being
investigated for its ability to reduce the overactive inflammatory
immune response associated with COVID-19.
IMPORTANT SAFETY INFORMATION FOR KEVZARA®
(sarilumab) INJECTION
KEVZARA can cause serious side effects including:
- SERIOUS INFECTIONS: KEVZARA is a medicine that
affects your immune system. KEVZARA can lower the ability of your
immune system to fight infections. Some people have serious
infections while using KEVZARA, including tuberculosis (TB), and
infections caused by bacteria, fungi, or viruses that can spread
throughout the body. Some people have died from these
infections. Your healthcare provider should test you for TB
before starting KEVZARA. Your healthcare provider should monitor
you closely for signs and symptoms of TB during treatment with
KEVZARA.
- Before starting KEVZARA, tell your healthcare provider if
you:
- think you have an infection or have symptoms of an infection,
with or without a fever. Symptoms may include sweats or chills,
muscle aches, a cough, shortness of breath, blood in your phlegm,
weight loss, warm, red, or painful skin or sores on your body,
diarrhea or stomach pain, burning when you urinate or urinating
more often than normal, if you feel very tired, or if you are being
treated for an infection, get a lot of infections or have repeated
infections
- have diabetes, HIV, or a weakened immune system
- have TB, or have been in close contact with someone with
TB
- live or have lived, or have traveled to certain parts of the
country (such as the Ohio and
Mississippi River valleys and the Southwest) where there is an
increased chance of getting certain fungal infections
(histoplasmosis, coccidioidomycosis, or blastomycosis)
- have or have had hepatitis
- After starting KEVZARA, call your healthcare provider right
away if you have any symptoms of an infection.
- CHANGES IN CERTAIN LABORATORY TEST RESULTS: Your
healthcare provider should do blood tests before and after starting
KEVZARA to check for low neutrophil (white blood cells that help
the body fight off bacterial infections) counts, low platelet
(blood cells that help with blood clotting and stop bleeding)
counts, and an increase in certain liver function tests. Changes in
test results are common with KEVZARA and can be severe. You
may also have changes in other laboratory tests, such as your blood
cholesterol levels. Your healthcare provider should do blood tests
4 to 8 weeks after starting KEVZARA and then every 6 months during
treatment to check for an increase in blood cholesterol
levels.
- TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Tell
your healthcare provider if you have had a condition known as
diverticulitis (inflammation in parts of the large intestine) or
ulcers in your stomach or intestines. Some people using KEVZARA had
tears in their stomach or intestine. This happens most often in
people who also take nonsteroidal anti-inflammatory drugs (NSAIDS),
corticosteroids, or methotrexate. Call your healthcare provider
right away if you have fever and stomach (abdominal) pain that does
not go away.
- CANCER: KEVZARA may increase your risk of certain
cancers by changing the way your immune system works. Tell
your healthcare provider if you have ever had any type of
cancer.
- SERIOUS ALLERGIC REACTIONS: Serious allergic reactions
can happen with KEVZARA. Get medical attention right away if
you have any of the following signs: shortness of breath or trouble
breathing; feeling dizzy or faint; swelling of your lips, tongue or
face; moderate or severe stomach (abdominal) pain or vomiting; or
chest pain.
- Do not use KEVZARA if you are allergic to Sarilumab or any of
the ingredients of KEVZARA.
- Before using KEVZARA, tell your healthcare provider if you
- have an infection
- have liver problems
- have had stomach (abdominal) pain or a condition known as
diverticulitis (inflammation in parts of the large intestine) or
ulcers in your stomach or intestines
- recently received or are scheduled to receive a vaccine.
People who take KEVZARA should not receive live vaccines
- plan to have surgery or a medical procedure
- are pregnant or plan to become pregnant. It is not known if
KEVZARA will harm your unborn baby
- are breastfeeding or plan to breastfeed. Talk to your
healthcare provider about the best way to feed your baby if you use
KEVZARA. It is not known if KEVZARA passes into your breast
milk
- take any prescription or nonprescription medicines, vitamins or
herbal supplements. It is especially important to tell your
healthcare provider if you use any other medicines to treat your
RA. Using KEVZARA with these medicines may increase
your risk of infection
- medicines that affect the way certain liver enzymes work. Ask
your healthcare provider if you are not sure if your medicine is
one of these
- The most common side effects include:
- injection site redness
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, and runny nose
These are not all the possible side effects of
KEVZARA. Tell your doctor about any side effect that
bothers you or does not go away. You are encouraged to report side
effects of prescription drugs to the FDA at www.fda.gov/medwatch or
call 1-800-FDA-1088.
Click here for full Prescribing Information including risk of
SERIOUS SIDE EFFECTS and Medication Guide for KEVZARA.
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.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100
countries, Sanofi is transforming scientific innovation
into healthcare solutions around the globe.
Sanofi, Empowering Life
Regeneron 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 nature, timing,
and possible success and therapeutic applications of products
marketed by Regeneron and/or its collaborators (collectively,
"Regeneron's Products") and Regeneron's product candidates and
research and clinical programs now underway or planned, including
without limitation Kevzara® (sarilumab) for the
treatment of patients with severe COVID-19 and
Regeneron's novel antibody cocktail for the prevention
and treatment of COVID-19 (the "COVID-19 Multi-antibody Therapy");
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products, such as Kevzara for the
treatment of patients with severe COVID-19 and the COVID-19
Multi-antibody Therapy; unforeseen safety issues resulting from the
administration of Regeneron's Products and product candidates (such
as Kevzara and the COVID-19 Multi-antibody Therapy) in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and product candidates in clinical
trials; 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
Kevzara and the COVID-19 Multi-antibody Therapy; ongoing regulatory
obligations and oversight impacting Regeneron's Products, research
and clinical programs, and business, including those relating to
patient privacy; 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) on the commercial success of
Regeneron's Products and product candidates; 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 Regeneron's Products and
product candidates; the extent to which the results from the
research and development programs conducted by Regeneron or its
collaborators may be replicated in other studies and lead to
therapeutic applications; 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), to
be cancelled or terminated without any further 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 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. 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).
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product
may not be commercially successful, the uncertainties inherent in
research and development, including future clinical data and
analysis of existing clinical data relating to the product,
including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic and
market conditions, the risk of global disruption, including
pandemics, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2019. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts:
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
Tel: +1 (914)
847-5018
Sarah.Cornhill@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
Sanofi
Contacts:
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Ashleigh.Koss@sanofi.com
|
Investor
Relations
Felix
Lauscher
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals