TARRYTOWN, N.Y., Oct. 28, 2020 /PRNewswire/ --
Today's data, involving an additional 524 patients from the
ongoing Phase 2/3 trial, provides definitive final virology results
and meets the clinical endpoint of reducing medical visits
Regeneron has shared these results with the U.S. FDA, which
is reviewing an Emergency Use Authorization submission for the
REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are
at high risk for poor outcomes
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
positive, prospective results from an ongoing Phase 2/3 seamless
trial in the COVID-19 outpatient setting showing its
investigational antibody cocktail, REGN-COV2, met the primary and
key secondary endpoints. REGN-COV2 significantly reduced viral load
and patient medical visits (hospitalizations, emergency room,
urgent care visits and/or physician office/telemedicine
visits).
"The first job of an antiviral therapeutic drug is to lower the
viral load, and our initial data in 275 patients strongly suggested
that the REGN-COV2 antibody cocktail could lower viral load and
thereby potentially improve clinical outcomes. Today's analysis,
involving more than 500 additional patients, prospectively confirms
that REGN-COV2 can indeed significantly reduce viral load and
further shows that these viral reductions are associated with a
significant decrease in the need for further medical attention,"
said George D. Yancopoulos, M.D.,
Ph.D., President and Chief Scientific Officer of Regeneron. "We
continue to see the strongest effects in patients who are most at
risk for poor outcomes due to high viral load, ineffective antibody
immune response at baseline, or pre-existing risk factors.
Regeneron has shared these results with the U.S. Food and Drug
Administration as part of its review of our Emergency Use
Authorization submission, and we continue to focus on completing
our ongoing trials evaluating REGN-COV2 for the treatment and
prevention of COVID-19."
The randomized, double-blind trial is measuring the effect of
adding REGN-COV2 to usual standard-of-care, compared to adding
placebo to standard-of-care. A descriptive analysis from the first
275 patients was previously reported. Today's data, involving an
additional 524 patients, show the trial met all of the first nine
endpoints in the statistical hierarchy, which assessed virologic
endpoints based on viral load, seronegative status and dose group,
as well as the key clinical endpoint of COVID-19 related
medically-attended visits, in patients who had laboratory-confirmed
COVID-19 at baseline. Results showed no significant difference in
virologic or clinical efficacy between the REGN-COV2 high dose (8
grams) and low dose (2.4 grams). Based on this finding, Regeneron
is reviewing potential changes to dosing in the ongoing outpatient
clinical trial given the current limited supply of REGN-COV2.
Virologic results (n=524, prospectively confirming previous
275-patient analysis):
- On the primary endpoint, the average daily change in viral load
through day 7 (mean time-weighted average change from baseline) in
patients with high viral load (defined as greater
than107 copies/mL) was a 0.68 log10 copies/mL greater
reduction with REGN-COV2 compared to placebo (combined dose groups;
p<0.0001). There was a 1.08 log greater reduction with REGN-COV2
treatment by day 5, which corresponds to REGN-COV2 patients having,
on average, a greater than 10-fold reduction in viral load,
compared to placebo.
- In the overall patient group with detectable virus at baseline,
the average daily reduction in viral load through day 7 was a 0.36
log10 copies/mL greater reduction with REGN-COV2 compared to
placebo (combined dose groups; p=0.0003).
- As in the earlier analysis, patients with higher viral load at
baseline and/or no detectable antibodies at baseline (suggesting
their bodies had not yet mounted an effective immune response),
derived greater benefit from REGN-COV2 therapy.
Clinical results in the overall population (n=799):
- On the key clinical endpoint, treatment with REGN-COV2 reduced
COVID-19 related medical visits by 57% through day 29 (2.8%
combined dose groups; 6.5% placebo; p=0.024).
- Treatment with REGN-COV2 reduced COVID-19 related medical
visits by 72% in patients with one or more risk factor (including
being over 50 years of age; body mass index greater than 30;
cardiovascular, metabolic, lung, liver or kidney disease; or
immunocompromised status) (combined dose groups; nominal p =
0.0065).
There was no planned formal statistical analysis of symptom
alleviation in this analysis; descriptive analyses did not reveal
robust associations with viral load, serology status or treatment.
REGN-COV2 was well tolerated in the trial. Serious adverse events
were numerically more frequent with placebo than REGN-COV2
treatment (0.8% high dose, 1.6% low dose; 2.3% placebo).
Numerically more infusion reactions occurred with the REGN-COV2
high dose compared to placebo (1.5% high dose; 0% low dose; 0.4%
placebo).
"We will submit detailed results from this trial for publication
in order to share insights with the public health and medical
communities," said David Weinreich, M.D., Senior Vice
President and Head of Global Clinical Development at
Regeneron. "We would like to thank the global investigators, sites
and patients who continue to work with us to conduct REGN-COV2
trials across different settings and geographies."
Additional Trial Background
In the overall patient
population (n=799), patients were prospectively characterized prior
to treatment by serology tests to see if they had already generated
antiviral antibodies on their own and were thus classified as
seronegative (no measurable antiviral antibodies) or seropositive
(measurable antiviral antibodies). Approximately 38% of patients
were seropositive, 51% were seronegative and 11% were categorized
as "other" due to unclear or unknown serology status. Approximately
50% of patients were Hispanic, 9% were African American and 60.5%
had one or more underlying risk factors for severe COVID-19,
including obesity (37%). On average, patients were 42.2 years
of age. In total, 47% of participants were male and 53% were
female.
The Phase 3 portion of this trial continues in non-hospitalized
patients. REGN-COV2 is also being studied in a Phase 2/3 clinical
trial for the treatment of COVID-19 in hospitalized patients, the
Phase 3 open-label RECOVERY trial of hospitalized patients in the
UK and a Phase 3 trial for the prevention of COVID-19 in household
contacts of infected individuals.
About REGN-COV2
REGN-COV2 is a combination of two
monoclonal antibodies (REGN10933 and REGN10987) and was designed
specifically to block infectivity of SARS-CoV-2, the virus that
causes COVID-19.
To develop REGN-COV2, Regeneron scientists 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.
REGN-COV2's development and manufacturing has been funded in
part with federal funds from 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 partnered with Roche to increase the global
supply of REGN-COV2 beginning in 2021. 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 eight
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 the development program
relating to REGN-COV2 (Regeneron's investigational dual antibody
for the treatment and prevention of COVID-19); whether the U.S.
Food and Drug Administration will grant an Emergency Use
Authorization ("EUA") for REGN-COV2 and, if an EUA is granted, how
long it would remain in effect for REGN-COV2; 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; the
ability of Regeneron to manufacture in anticipated quantities
Regeneron's Products and product candidates, including REGN-COV2;
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; 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 studies discussed in this press release, on any potential
regulatory approval (including with respect to REGN-COV2) 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; 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 relating to REGN-COV2,
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 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 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
Tel: +1 (914) 847-3407
alexandra.bowie@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.