TARRYTOWN, N.Y. and
PARIS, March 30, 2020 /PRNewswire/ --
Phase 2/3 trial initiated in Italy, Spain,
Germany, France, Japan, Canada
and Russia and is enrolling
patients immediately
Kevzara inhibits IL-6, which may play a role
in driving the inflammatory immune response that causes acute
respiratory distress syndrome observed in patients with severe
COVID-19 infection
Regeneron is leading U.S. trials, Sanofi is
leading ex-U.S. trials
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced the first patient outside of the U.S. has
been treated as part of a global clinical program evaluating
Kevzara® (sarilumab) in patients hospitalized with
severe COVID-19. The global clinical program has now been initiated
in Italy, Spain, Germany, France, Canada, Russia and the
United States – all countries that have been impacted by
COVID-19.
This is the second multi-center, double-blind, Phase 2/3 trial
as part of the Kevzara COVID-19 program, and the companies are
continuing to work with health authorities around the world to
secure initiation at additional sites. This follows Regeneron and
Sanofi's announcement earlier this month of the initiation of the
first trial, which is U.S.-based.
"Data from a single-arm study in China suggest that the interleukin-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 of Kevzara, which we are now
doing through this global clinical trial program," said
George D. Yancopoulos, M.D., Ph.D.,
Co-founder, President and Chief Scientific Officer of Regeneron.
"In addition to the Kevzara program, Regeneron continues to rapidly
advance a novel antibody cocktail for the prevention and treatment
of COVID-19."
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 infection. The role of IL-6 is
supported by preliminary data from a single-arm study in
China using another IL-6 receptor
antibody.
"Sanofi and Regeneron are relentlessly working to rapidly
initiate trials around the world that will help determine whether
Kevzara has the potential to play a role in addressing the COVID-19
disease global health crisis. These trials will provide important
data to determine whether Kevzara ameliorates the life-threatening
complications of COVID-19 infections by counteracting the
overactive inflammatory immune responses in the lungs when damaged
by the virus. In these unprecedented times, we are deeply grateful
for the daily collaboration with health authorities that is
enabling us to conduct this clinical work so quickly," said
John Reed, M.D., Ph.D., Sanofi's
Global Head of Research and Development. "In addition to this
clinical trial aiming to help critically ill COVID-19 patients, our
work continues to bring forth a vaccine for disease prevention,
along with efforts to provide other important Sanofi medicines that
may help patients impacted by COVID-19."
The trial outside of the U.S. will assess the safety and
efficacy of adding a single intravenous dose of Kevzara to usual
supportive care, compared to supportive care plus placebo. The
trial has an adaptive design with two parts and is anticipated to
enroll approximately 300 patients. The trial will recruit
hospitalized patients from several countries who are severely or
critically ill with COVID-19 infection.
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. In an initial, non-peer-reviewed case series from
China, a 21-patient cohort of
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 another IL-6 receptor antibody
(tocilizumab). Based on these results, China updated its COVID-19 treatment
guidelines and approved the use of that IL-6 inhibitor to treat
patients with severe or critical disease.
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 have pneumonia and be hospitalized with
laboratory-confirmed COVID-19 that is classified as severe or
critical, or who are suffering from multi-organ dysfunction. 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 higher dose, Kevzara lower dose
and placebo. 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.
If the trial continues with all three treatment arms to the end,
it is expected to enroll approximately 300 patients, depending on
the status of the COVID-19 outbreak and the proportion of patients
with severe COVID-19.
About Kevzara® (sarilumab)
Injection
Kevzara is currently approved in multiple
countries to treat adults with moderately to severely active
rheumatoid arthritis who have not responded to or tolerated
previous therapy.
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 an
immune system protein produced in increased quantities in patients
with rheumatoid arthritis and has been associated with disease
activity, joint destruction and other systemic problems. Kevzara is
being investigated for its ability to reduce the overactive
inflammatory immune response associated with COVID-19 based on
evidence of markedly elevated levels of IL-6 in severely ill
patients infected with coronaviruses.
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.
WHAT IS KEVZARA?
Kevzara is an injectable prescription medicine called an
interleukin-6 (IL-6) receptor blocker. Kevzara is used to treat
adult patients with moderately to severely active rheumatoid
arthritis (RA) after at least one other medicine called a
disease-modifying antirheumatic drug (DMARD) has been used and did
not work well or could not be tolerated.
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
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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
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relating to Dupixent® (dupilumab) and
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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
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Regeneron uses its media and investor relations website and
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Contacts:
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
Tel: +1 (914)
847-5018
Sarah.Cornhill@regeneron.com
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Investor
Relations
Justin
Holko
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847-7786
Justin.Holko@regeneron.com
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Sanofi
Contacts:
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Relations
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Relations
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45 45
ir@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.