TARRYTOWN, N.Y., Sept. 29, 2020 /PRNewswire/ --
Greatest improvements in patients who had not mounted their
own effective immune response prior to treatment
Plan rapidly to discuss results with regulatory
authorities
Regeneron to host investor and media webcast to discuss
results at 4:30 pm ET today
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
the first data from a descriptive analysis of a seamless Phase
1/2/3 trial of its investigational antibody cocktail REGN-COV2
showing it reduced viral load and the time to alleviate symptoms in
non-hospitalized patients with COVID-19. REGN-COV2 also showed
positive trends in reducing medical visits. The ongoing,
randomized, double-blind trial measures the effect of adding
REGN-COV2 to usual standard-of-care, compared to adding placebo to
standard-of-care.
This trial is part of a larger program that also includes
studies of REGN-COV2 for the treatment of hospitalized patients,
and for prevention of infection in people who have been exposed to
COVID-19 patients.
"After months of incredibly hard work by our talented team, we
are extremely gratified to see that Regeneron's antibody cocktail
REGN-COV2 rapidly reduced viral load and associated symptoms in
infected COVID-19 patients," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. "The greatest treatment benefit was in
patients who had not mounted their own effective immune response,
suggesting that REGN-COV2 could provide a therapeutic substitute
for the naturally-occurring immune response. These patients were
less likely to clear the virus on their own, and were at greater
risk for prolonged symptoms. We are highly encouraged by the robust
and consistent nature of these initial data, as well as the
emerging well-tolerated safety profile, and we have begun
discussing our findings with regulatory authorities while
continuing our ongoing trials. In addition to having positive
implications for REGN-COV2 trials and those of other antibody
therapies, these data also support the promise of vaccines
targeting the SARS-CoV-2 spike protein."
The descriptive analysis included the first 275 patients
enrolled in the trial and was designed to evaluate anti-viral
activity with REGN-COV2 and identify patients most likely to
benefit from treatment; the next cohort, which could be used to
rapidly and prospectively confirm these results, has already been
enrolled. Patients in the trial were randomized 1:1:1 to receive a
one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of
REGN-COV2 (low dose) or placebo. All patients entering the trial
had laboratory-confirmed COVID-19 that was being treated in the
outpatient setting. Patients were prospectively characterized prior
to treatment by serology tests to see if they had already generated
antiviral antibodies on their own and were classified as
seronegative (no measurable antiviral antibodies) or seropositive
(measurable antiviral antibodies). Approximately 45% of patients
were seropositive, 41% were seronegative and 14% were categorized
as "other" due to unclear or unknown serology status.
Key data findings include:
Note that since this
analysis was considered descriptive, all p-values are
nominal.
- As hypothesized, patients in the study consisted of two
different populations: those who had already mounted an effective
immune response, and those whose immune response was not yet
adequate. These populations could be identified serologically by
the presence (seropositive) or absence (seronegative) of SARS-CoV-2
antibodies, and/or by high viral loads at baseline.
- Serological status highly correlated with baseline viral
load (p<0.0001). Seropositive patients had much lower levels
of virus at baseline, and rapidly achieved viral loads approaching
lowest levels quantifiable (LLQ), even without treatment. In
contrast, seronegative patients had substantially higher viral
levels at baseline, and cleared virus more slowly in the absence of
treatment.
- Serological status at baseline also predicted how rapidly
patients had alleviation of their COVID-19 clinical symptoms.
In the untreated (placebo) patients, seropositive patients had a
median time to alleviation of symptoms of 7 days, compared to
seronegative patients who had a median time to alleviation of
symptoms of 13 days.
- REGN-COV2 rapidly reduced viral load through Day 7 in
seronegative patients (key virologic endpoint). The mean
time-weighted-average change from baseline nasopharyngeal (NP)
viral load through Day 7 in the seronegative group was a 0.60 log10
copies/mL greater reduction (p=0.03) in patients treated with high
dose, and a 0.51 log10 copies/mL greater reduction (p=0.06) in
patients treated with low dose, compared to placebo. In the overall
population, there was a 0.51 log10 copies/mL greater reduction
(p=0.0049) in patients treated with high dose, and a 0.23 log10
copies/mL greater reduction (p= 0.20) in patients treated with low
dose, compared to placebo.
- Patients with increasingly higher baseline viral levels had
correspondingly greater reductions in viral load at Day 7 with
REGN-COV2 treatment. The mean log10 copies/mL reduction in
viral load compared to placebo were as follows:
- Viral load higher than 105 copies/mL: high dose
(-0.93); low dose (-0.86) (p=0.03 for both); approximately 50-60%
reduction compared to placebo
- Viral load higher than 106 copies/mL: high dose
(-1.55); low dose (-1.65) (p<0.002 for both); approximately 95%
reduction compared to placebo
- Viral load higher than 107 copies/mL: high dose
(-1.79); low dose (-2.00) (p<0.0015 for both); approximately 99%
reduction compared to placebo
- Patients who were seronegative and/or had higher baseline
viral levels also had greater benefits in terms of symptom
alleviation. Among seronegative patients, median time to
symptom alleviation (defined as symptoms becoming mild or absent)
was 13 days in placebo, 8 days in high dose (p=0.22), and 6 days in
low dose (p=0.09). Patients with increasing viral loads at baseline
had correspondingly increasing benefit in time to symptom
alleviation.
- There were a small number of medically-attended visits given
that most non-hospitalized patients recover well at home.
Patients in the seronegative group were at higher risk of
medically-attended visits: 10 of the 12 medically-attended visits
(defined as hospitalizations, or emergency room, urgent care or
telemedicine visits for COVID-19) occurred in patients who were
seronegative at baseline. In the seronegative group, 15.2% of
placebo-treated patients, 7.7% of patients treated with high dose
and 4.9% of patients treated with low dose required additional
medical visits.
- Both doses were well-tolerated. Infusion reactions were
seen in 4 patients (2 on placebo and 2 on REGN-COV2). Serious
adverse events occurred in 2 placebo patients, 1 low dose patient
and no high dose patients. There were no deaths in the trial.
More than 2,000 people have been enrolled across the overall
REGN-COV2 development program, and no unexpected safety findings
have been reported by the Independent Data Monitoring
Committee.
"Thank you to the global investigators, sites and patients who
continue to work with us to conduct REGN-COV2 trials, especially
given the unique challenges posed by the pandemic," said
David Weinreich, M.D., Senior Vice
President and Head of Global Clinical Development at Regeneron. "We
plan rapidly to submit detailed results from this analysis for
publication in order to share insights with the public health and
medical communities. Regeneron continues to enroll patients in this
trial and all other ongoing late-stage trials evaluating
REGN-COV2."
Additional Trial Background
Among the first 275
patients, approximately 56% were Hispanic, 13% were African
American and 64% had one or more underlying risk factors for severe
COVID-19, including obesity (more than 40%). On average, patients
were 44 years of age. In total, 49% of participants were male and
51% were female.
At least 1,300 patients will be recruited into the Phase 2/3
portion of the outpatient trial overall. Patients will be followed
for 29 days, with viral shedding in the upper respiratory tract
assessed approximately every 2-3 days in the Phase 2 portion of the
trial and clinical endpoints assessed via investigator and
patient-reported data throughout.
In addition to this trial in non-hospitalized patients,
REGN-COV2 is currently 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. Recruitment in all 4 trials is
ongoing.
Investor and Media Webcast Information
Regeneron will
host a conference call and simultaneous webcast to share updates on
REGN-COV2 today September 29, 2020 at
4:30 pm ET. To access the call, dial
(888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to
the webcast may be accessed from the "Investors and Media" page of
Regeneron's website at www.regeneron.com. A replay of the
conference call and webcast will be archived on the Company's
website and will be available for at least 30 days.
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. Preclinical studies have shown that REGN-COV2
reduced the amount of virus and associated damage in the lungs of
non-human primates.
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 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 the development program
relating to REGN-COV2 (Regeneron's investigational two-antibody
cocktail for the treatment and prevention of COVID-19) discussed in
this press release; 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; the extent to which the results from the research and
development programs conducted by Regeneron and/or its
collaborators (including without limitation the data from a
descriptive analysis of a seamless Phase 1/2/3 trial evaluating
REGN-COV2 discussed in this press release) may be replicated and/or
lead to advancement of product candidates to clinical trials,
therapeutic applications, or regulatory approval; 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 those 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 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 relating to REGN-COV2 discussed in this press release,
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 (such as the pending civil litigation
initiated by the U.S. Attorney's Office for the District of
Massachusetts), 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-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.