TARRYTOWN, N.Y., Feb. 27, 2021 /PRNewswire/ --
Single administration of novel antibody cocktail controlled
patients' allergic response to cat allergen, preventing early
asthma reactions for the duration of the 3-month trial
Patients experienced significant improvements in lung
function and cat allergen tolerance from the first assessment at
week 1
Results presented at the virtual 2021 AAAAI Annual
Meeting
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
detailed results from a Phase 2 proof-of-concept trial evaluating
the investigational antibody cocktail REGN1908-1909 in cat-allergic
patients with mild asthma. The trial met the primary endpoint of
preventing early asthma reactions (EAR, defined as a ≥20% decline
in forced expiratory volume over one second [FEV1]). The
trial also met key secondary endpoints, including improved lung
function and an increased amount of cat allergen that patients
could tolerate following a single dose of treatment, from as early
as the first assessment conducted at week 1. The results were
shared in an oral presentation at the virtual 2021 American Academy
of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.
"Cat allergy is one of the most common allergic respiratory
diseases, impacting millions of people who must alter their lives
by withdrawing from certain social situations, occupations and
relationships. For those with co-existing asthma, cat allergies can
trigger exacerbations that, although rare, can lead to
hospitalization," said Frederic J. de
Blay, M.D., Professor of Pulmonology and Allergist at the
Strasbourg University and
principal investigator of the trial performed at
ALYATEC. "These encouraging trial results showed that a single
dose of REGN1908-1909 prevented early asthma reactions in
cat-allergic patients with mild asthma rapidly and durably – as
early as one week after treatment and up to three months."
Cat allergy is primarily caused by exposure to Fel d 1, the
major allergen in cat dander produced by all cats. Fel d 1 is
spread to surrounding environments through airborne particles that
adhere to clothing, carpets and furniture. Patients typically
experience rapid onset of mild to severe symptoms including nasal
congestion, itchy and watery eyes, chest tightening and wheezing.
Currently, cat-induced allergic rhinitis is treated with
antihistamines and intranasal corticosteroids with moderate
efficacy. Allergen-specific immunotherapy (otherwise known as
allergy shots) takes 12-24 months to see clinical benefit and is
contraindicated for patients with severe or uncontrolled asthma.
Importantly, the association between cat allergy and asthma is
significant, as more than 50% of cat-allergic patients have
co-existing asthma. Although rare, cat allergy in these patients
can potentially trigger life-threatening asthma attacks leading to
hospitalization.
REGN1908-1909 is a novel cocktail of two fully-human monoclonal
IgG antibodies, designed to specifically bind and block the Fel d 1
allergen, thus preventing it from binding and triggering the
endogenous antibodies that cause allergies (i.e., Immunoglobulin E,
or IgE, antibodies). REGN1908-1909 was invented using Regeneron's
proprietary VelocImmune®
technology.
"These data add further evidence supporting a completely new way
to combat common allergies," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "Under this new approach pioneered by
Regeneron, patients are given antibodies that provide immediate and
durable protection against offending allergens, a type of passive
immunity. We have developed and are currently studying several
allergen-specific antibodies, including REGN1908-1909 for cat
allergy and a Phase 3 trial investigating REGN5713-5715 in patients
with birch allergy."
The Phase 2 randomized, double-blind proof-of-concept trial
enrolled 56 cat-allergic patients with mild asthma who received a
single dose of REGN1908-1909 600 mg or placebo delivered
subcutaneously. This was followed by a 12-week assessment period
during which patients underwent a 4-hour Cat Allergen Challenge
(CAC) at weeks 1, 4, 8 and 12 in an environmental exposure unit
(EEU) where they were exposed to cat allergen and monitored for
allergic reactions. In order to establish a baseline, patients were
also exposed to the EEU 1 week prior to receiving either
REGN1908-1909 or placebo.
Patients who took REGN1908-1909 experienced significant
improvements during the Cat Allergen Challenge compared to those on
placebo, which included:
- Reduced time to EAR for up to 3 months: REGN1908-1909
significantly extended the median time before patients experienced
an early asthma reaction compared to placebo at all time points
assessed, including at week 1 (>4 hours REGN1908-1909 vs. 51
minutes placebo, p=0.0083, the primary endpoint).
- Improved ability to breathe: REGN1908-1909 prevented 68%
of the lung function decline observed upon cat allergen exposure,
compared to 23% with placebo (measured by comparing the lung
function decline induced by cat allergen exposure pre-treatment,
with that seen 1 week following treatment; similar benefit was seen
throughout the 3-month post-treatment assessment period).
- Improved cat allergen tolerance: Patients taking
REGN1908-1909 were able to tolerate a three-fold higher allergen
quantity from baseline without experiencing an early asthma
reaction compared to placebo (60 nanograms [ng] REGN1908-1909 vs.
20 ng placebo, p=0.003).
Adverse events (AEs) occurred in 76% of patients who received
REGN1908-1909 and 78% of patients who received placebo. AEs more
commonly observed with those receiving REGN1908-1909 included
injection site reactions (7% for REGN1908-1909, 4% for
placebo).
The use of REGN1908-1909 to treat cat-allergic patients with
mild asthma is investigational and its efficacy and safety have not
been fully evaluated by any regulatory authority.
About the Phase 2 Trial
The randomized, double-blind,
parallel-group, single-dose proof-of-concept trial enrolled 56
cat-allergic patients with mild asthma who were not living with a
cat. The trial consisted of up to a 12-week screening period
followed by 1:1 randomization on day 1 to receive 600 mg
REGN1908-1909 or placebo administered subcutaneously, followed by a
12-week assessment period and a 4-week safety follow-up period.
During the screening period, patients underwent a 2-hour CAC in an
EEU after initially being evaluated in a placebo challenge.
Patients performed spirometry every 10 minutes during the EEU CAC
until they experienced an EAR, or bronchoconstriction when their
FEV1 was reduced by ≥20%. Following the CAC,
patients were monitored for 6 hours and those meeting eligibility
requirements were then randomized to receive a single 600 mg
subcutaneous dose of REGN1908-1909 or placebo, and returned to the
trial site to undergo a 4-hour CAC in the EEU (plus a 6-hour
observation period) at weeks 1, 4, 8 and 12 following treatment
administration.
The primary endpoint was prevention of EAR, as measured by
FEV1, compared to placebo 1 week after treatment,
following the CAC. Key secondary endpoints included the prevention
of EAR on weeks 4, 8 and 12; change in FEV1 on
weeks 1, 4, 8 and 12; and change in cat allergen quantity, as
experienced by patients during exposure on weeks 1, 4, 8 and
12.
About Regeneron's VelocImmune®
Technology
REGN1908-1909 was invented using Regeneron's
VelocImmune technology that utilizes a proprietary
genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. When Regeneron's co-Founder, President and
Chief Scientific Officer George D.
Yancopoulos was a graduate student with his mentor
Frederick W. Alt in 1985, they were
the first to envision making such a genetically-humanized mouse,
and Regeneron has spent decades inventing and developing
VelocImmune and related
VelociSuite® technologies. Dr.
Yancopoulos and his team have used VelocImmune technology to
create multiple antibodies including
Dupixent® (dupilumab),
Libtayo®, Praluent®
(alirocumab), Kevzara® (sarilumab),
Evkeeza™ (evinacumab-dgnb), Inmazeb™
(atoltivimab, maftivimab, and odesivimab-ebgn) and Regeneron's
antibody cocktail for COVID-19, which was recently granted
Emergency Use Authorization (EUA) in 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 nine
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, 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 being developed by Regeneron and/or its collaborators
(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
limitation the investigational Fel d 1 antibody cocktail
REGN1908-1909; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's Product
Candidates, such as REGN1908-1909 for the treatment of cat allergic
patients with mild asthma (as well as other potential indications),
and new indications for Regeneron's Products; uncertainty of market
acceptance and commercial success of Regeneron's Products and
Regeneron's Product Candidates and the impact of studies (whether
conducted by Regeneron or others and whether mandated or
voluntary), including the study discussed in this press release, on
the commercial success of Regeneron's Products and Regeneron's
Product Candidates (such as REGN1908-1909); safety issues resulting
from the administration of Regeneron's Products and Regeneron's
Product Candidates (such as REGN1908-1909) in patients, including
serious complications or side effects in connection with the use of
Regeneron's Products and Regeneron's 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 Regeneron's Product Candidates; 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 Regeneron's 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; 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 Regeneron's 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, collaboration, or supply 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; 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),
Praluent® (alirocumab), and REGEN-COVTM
(casirivimab and imdevimab)), 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, 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).
Media
Relations
Sharon
Chen
Tel: +1 (914)
847-1546
Sharon.Chen@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-announces-positive-phase-2-data-evaluating-fel-d-1-antibody-cocktail-in-cat-allergic-patients-with-mild-asthma-301236868.html
SOURCE Regeneron Pharmaceuticals, Inc.