TARRYTOWN, N.Y., Jan. 26, 2021 /PRNewswire/ --
Reduction in overall infections seen within first week, with
100% prevention of symptomatic infections
Markedly decreased levels and duration of viral shedding in
asymptomatic infections that still occurred in REGEN-COV
group
Confirmatory Phase 3 results expected early in second
quarter
Potential application in people who need immediate protection
or respond poorly to vaccination
REGEN-COV 1,200 mg administered by subcutaneous injection,
providing greater convenience and efficiency than infusion
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
positive initial results from an ongoing Phase 3 clinical trial
evaluating REGEN-COV™
(casirivimab and imdevimab antibody cocktail) used as a passive
vaccine for the prevention of COVID-19 in people at high risk of
infection (due to household exposure to a COVID-19 patient). The
trial is being run jointly with the National Institute of
Allergy and Infectious Diseases (NIAID), part of
the National Institutes of Health (NIH).
An exploratory analysis was conducted on the first approximately
400 evaluable individuals enrolled in the trial, who were
randomized to receive passive vaccination with REGEN-COV (1,200 mg
via subcutaneous injections) or placebo. Results included:
- Passive vaccination with REGEN-COV resulted in 100% prevention
of symptomatic infection (8/223 placebo vs. 0/186 REGEN-COV), and
approximately 50% lower overall rates of infection (symptomatic and
asymptomatic) (23/223 placebo vs. 10/186 REGEN-COV).
- The lower number of infections occurring with REGEN-COV therapy
were all asymptomatic, with decreased peak virus levels and short
duration of viral shedding.
-
- Infections occurring in the placebo group had, on average, more
than 100-fold higher peak viral load.
- Infections in the REGEN-COV group lasted no more than 1 week,
while approximately 40% of infections in the placebo group lasted
3-4 weeks.
- No infected individuals in the REGEN-COV group had high viral
loads (>10^4 copies/mL) compared to 62% of the infected placebo
group (13/21 placebo vs. 0/9 REGEN-COV).
- REGEN-COV was associated with lower disease burden:
-
- Fewer total viral shedding weeks (44 weeks placebo vs. 9 weeks
REGEN-COV).
- Fewer total high viral shedding weeks (>10^4 copies/mL) (22
weeks placebo vs. 0 weeks REGEN-COV).
- Fewer total symptomatic weeks (18 weeks placebo vs. 0 weeks
REGEN-COV).
"These data using REGEN-COV as a passive vaccine suggest that it
may both reduce transmission of the virus as well as reduce viral
and disease burden in those who still get infected," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "Even with the
emerging availability of active vaccines, we continue to see
hundreds of thousands of people infected daily, actively spreading
the virus to their close contacts. The REGEN-COV antibody cocktail
may be able to help break this chain by providing immediate passive
immunity to those at high risk of infection, in contrast to active
vaccines which take weeks to provide protection. There are also
many individuals who unfortunately may be immunocompromised and not
respond well to an active vaccine or are otherwise unable to be
vaccinated, and REGEN-COV has the potential to be an important
option for these individuals. Overall, the REGEN-COV development
program has demonstrated definitive anti-viral activity and the
collective data strongly suggest it can be effective both as a
therapeutic and as a passive vaccine."
In the safety assessment, adverse events occurred more
frequently in participants on placebo (18% placebo vs. 12%
REGEN-COV); this difference was driven by the increased rate of
SARS-CoV-2 infections in the placebo group. In the placebo group,
there was one death and one COVID-19-related hospitalization; there
were no deaths or COVID-19 hospitalizations in the treatment group.
Injection site reactions occurred at a rate of approximately 2% in
both treatment and placebo groups.
"In this prevention trial, REGEN-COV was given as injections
rather than an infusion, which makes administration much more
convenient and efficient for patients and overburdened healthcare
providers and facilities," said David
Weinreich, M.D., Executive Vice President and Head of Global
Clinical Development at Regeneron. "It's notable that the few
infections that did occur after receiving REGEN-COV were all
asymptomatic, and associated with markedly lower viral load and
duration of viral shedding, potentially further reducing
transmission. We look forward to seeing the full dataset early next
quarter and will discuss the current results with regulatory
authorities, including the potential to expand the Emergency Use
Authorization."
The development and manufacturing of REGEN-COV has been funded
in part with federal funds from the Biomedical Advanced
Research and Development Authority (BARDA), part of the U.S.
Department of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response, under OT
number: HHSO100201700020C. Under agreements with the U.S.
Government, Regeneron is supplying up to approximately 1.5 million
doses of REGEN-COV for treatment of COVID-19 under the current
Emergency Use Authorization (EUA). In November, REGEN-COV was
granted an EUA by the U.S. Food and Drug Administration (FDA) for
use in treating people with mild or moderate COVID-19 who are at
high risk of developing severe symptoms and requiring
hospitalization and are not currently hospitalized. The EUA is
temporary and does not take the place of a formal biologics
license application (BLA) review and approval process and the use
of the antibody cocktail remains investigational. Evaluation of its
safety and efficacy is ongoing in multiple clinical trials.
About the REGEN-COV Phase 3 Prevention Trial
This
trial evaluated the use of REGEN-COV as a "passive vaccine" to
prevent SARS-CoV-2 infection. Passive vaccination provides
immediate short-term passive immunity, by delivering protective
virus-neutralizing antibodies, either through therapeutic antibody
medicines like REGEN-COV or from mother to child through
breastmilk. Traditional vaccines work by activating the immune
system to develop its own antibodies, a process that typically
takes weeks, but provides longer-term active immunity.
The initial descriptive analysis included 409 evaluable
participants enrolled early in the trial who did not have COVID-19
at baseline and were "seronegative," meaning they did not have
existing antibodies in their blood to SARS-CoV-2. Individuals were
eligible for the trial if they had a household member with
COVID-19. Participants were tested weekly by nasopharyngeal swab.
The confirmatory results will evaluate the ability of REGEN-COV to
prevent asymptomatic and symptomatic COVID-19 infections as the
primary endpoint. The trial has enrolled over 2,000
participants.
Among the first 409 participants, approximately 49% were
Hispanic and 13% were African American. On average, participants
were 43 years of age, approximately 46% were male and 54% were
female.
In addition to the Phase 3 trial for the prevention of COVID-19,
REGEN-COV is being studied in two late-stage hospitalized patient
trials and a Phase 3 trial for the treatment of non-hospitalized
patients.
About REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab and imdevimab) is a cocktail of two monoclonal
antibodies (also known as REGN10933 and REGN10987) and was designed
specifically to block infectivity of SARS-CoV-2, the virus that
causes COVID-19. The two potent, virus-neutralizing antibodies
that form the cocktail 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.
In November 2020, REGEN-COV
received an EUA from the FDA for the treatment of mild to moderate
COVID-19 in adults, as well as in pediatric patients at least 12
years of age and weighing at least 40 kg, who have received
positive results of direct SARS-CoV-2 viral testing and are at high
risk for progressing to severe COVID-19 and/or hospitalization. The
clinical evidence from Regeneron's outpatient trial suggests that
monoclonal antibodies such as casirivimab and imdevimab have the
greatest benefit when given early after diagnosis and in patients
who are seronegative and/or who have high viral load. The criteria
for 'high-risk' patients are described in the Fact Sheet for
Healthcare Providers. In the U.S., casirivimab and imdevimab are
not authorized for use in patients who are hospitalized due to
COVID-19 or require oxygen therapy, or for people currently using
chronic oxygen therapy because of an underlying comorbidity who
require an increase in baseline oxygen flow rate due to
COVID-19.
Regeneron is collaborating with Roche to increase global
supply of REGEN-COV. Regeneron is responsible for development and
distribution of the treatment in the U.S., and Roche is primarily
responsible for development and distribution outside the U.S. The
companies share a commitment to making the antibody cocktail
available to COVID-19 patients around the globe and will support
access in low- and lower-middle-income countries through drug
donations to be made in partnership with public health
organizations.
AUTHORIZED USE AND IMPORTANT SAFETY
INFORMATION
Authorized Emergency Use
Casirivimab and imdevimab injection is an investigational
combination therapy and has been authorized by FDA for the
emergency use described above. Casirivimab and imdevimab injection
is not FDA approved for any use. Safety and effectiveness of
casirivimab and imdevimab injection have not yet been established
for the treatment of COVID-19.
This authorized use is only for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency use under section 564 (b)(1) of the Act, 21 U.S.C. §
360bbb-3(b) (1), unless the authorization is terminated or revoked
sooner.
Limitations of Authorized Use
- Casirivimab and imdevimab injection is not authorized for use
in patients:
-
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to
COVID-19 in those on chronic oxygen therapy due to underlying
non-COVID-19 related comorbidity.
- Benefit of treatment with casirivimab and imdevimab injection
has not been observed in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as casirivimab and imdevimab, may be
associated with worse clinical outcomes when administered to
hospitalized patients requiring high flow oxygen or mechanical
ventilation with COVID-19.
Definition of High-Risk Patients
High-risk is defined as patients who meet at least one of the
following criteria:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- Are ≥55 years of age AND have
-
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory
disease.
- Are 12 – 17 years of age AND have
-
- BMI ≥85th percentile for their age and gender based on CDC
growth charts, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, cerebral palsy,
OR
- a medical-related technological dependence, for example,
tracheostomy, gastrostomy, or positive pressure ventilation (not
related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease
that requires daily medication for control.
Warnings and Precautions:
- Hypersensitivity Including Anaphylaxis and Infusion-Related
Reactions: There is a potential for serious
hypersensitivity reaction, including anaphylaxis, with
administration of casirivimab and imdevimab injection. If signs or
symptoms of a clinically significant hypersensitivity reaction or
anaphylaxis occur, immediately discontinue administration and
initiate appropriate medications and/or supportive therapy.
Infusion-related reactions have been observed with administration
of casirivimab and imdevimab injection. Signs and symptoms of
infusion related reactions may include fever, chills, nausea,
headache, bronchospasm, hypotension, angioedema, throat irritation,
rash including urticaria, pruritus, myalgia, and/or dizziness. If
an infusion-related reaction occurs, consider slowing or stopping
the infusion and administer appropriate medications and/or
supportive care.
- Limitations of Benefit and Potential for Risk in Patients
with Severe COVID-19: Benefit of treatment with
casirivimab and imdevimab injection has not been observed in
patients hospitalized due to COVID-19. Monoclonal antibodies, such
as casirivimab and imdevimab, may be associated with worse clinical
outcomes when administered to hospitalized patients requiring high
flow oxygen or mechanical ventilation with COVID-19. Therefore,
casirivimab and imdevimab injection is not authorized for use in
who are hospitalized due to COVID-19, OR who require oxygen therapy
due to COVID-19, OR who require an increase in baseline oxygen flow
rate due to COVID-19 in those on chronic oxygen therapy due to
underlying non-COVID-19 related comorbidity.
Adverse Reactions:
- Serious adverse events (SAEs) were reported in 4 (1.6%)
patients in the casirivimab and imdevimab injection 2,400 mg group,
2 (0.8%) patients in casirivimab and imdevimab injection 8,000 mg
group and 6 (2.3%) patients in the placebo group. None of the SAEs
were considered to be related to study drug. SAEs that were
reported as Grade 3 or 4 adverse events were pneumonia,
hyperglycemia, nausea and vomiting (2,400 mg casirivimab and
imdevimab injection), intestinal obstruction and dyspnea (8,000 mg
casirivimab and imdevimab injection) and COVID-19, pneumonia and
hypoxia (placebo). Casirivimab and imdevimab injection are not
authorized at the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg
imdevimab).
Patient Monitoring Recommendations: Clinically monitor
patients during infusion and observe patients for at least 1 hour
after infusion is complete.
Use in Specific Populations:
- Pregnancy: There is currently limited clinical
experience in the use of casirivimab and imdevimab injection in
COVID-19 patients who are pregnant. Casirivimab and imdevimab
injection therapy should be used during pregnancy only if the
potential benefit justifies the potential risk for the mother and
the fetus.
- Nursing Mothers: There is currently no clinical
experience in use of casirivimab and imdevimab injection in
COVID-19 patients who are breastfeeding. The development and health
benefits of breastfeeding should be considered along with the
mother's clinical need for casirivimab and imdevimab injection and
any potential adverse effects on the breastfed child from
casirivimab and imdevimab injection or from the underlying maternal
condition.
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 eight
FDA-approved treatments and numerous product candidates in
development, almost 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 or referenced in this press
release), Regeneron's ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized 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 the
development program relating to REGEN-COVTM (casirivimab
and imdevimab antibody cocktail); how long the Emergency Use
Authorization ("EUA") granted by the U.S. Food and Drug
Administration (the "FDA") for REGEN-COV will remain in effect,
whether and to what extent the EUA may be expanded (including based
on the data from the ongoing Phase 3 clinical trial discussed in
this press release), and whether the EUA is revoked by the FDA
based on its determination that the underlying health emergency no
longer exists or warrants such authorization or other reasons; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's product candidates (such as
REGEN-COV) and new indications for Regeneron's Products; 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 (including
REGEN-COV) and the impact of the foregoing on Regeneron's ability
to supply its Products and product candidates, including its
ability to supply doses of REGEN-COV under the terms of the
agreements with the U.S. government referenced in this press
release (collectively, the "Manufacturing and Supply Agreement");
whether and to what extent Regeneron will be able to supply doses
of REGEN-COV under the Manufacturing and Supply Agreement; whether
the Manufacturing and Supply Agreement is terminated by the U.S.
government or otherwise prior to completion; the ability of
Regeneron to manage supply chains for multiple products and product
candidates; safety issues resulting from the administration of
Regeneron's Products and product candidates (such as REGEN-COV) in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and product
candidates in clinical trials (including those discussed or
referenced in this press release); 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 trials discussed or referenced in this press release, on any
potential regulatory approval (including with respect to REGEN-COV)
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
REGEN-COV; 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; 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, collaboration, or supply 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
relating to REGEN-COV, to be cancelled or terminated; 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 September 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 or otherwise) 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
media@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-positive-interim-data-with-regen-cov-antibody-cocktail-used-as-passive-vaccine-to-prevent-covid-19-301214619.html
SOURCE Regeneron Pharmaceuticals, Inc.