TARRYTOWN, N.Y. and
PARIS, June
6, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that a one-year
Phase 3 study, known as LIBERTY AD CHRONOS, evaluating
investigational dupilumab met its primary and key secondary
endpoints. In the study, dupilumab with topical corticosteroids
(TCS) was compared to TCS alone in moderate-to-severe atopic
dermatitis (AD) adult patients. Patients in the study were
inadequately controlled by topical corticosteroids (TCS) with or
without topical calcineurin inhibitors (TCI). Dupilumab with TCS
significantly improved measures of overall disease severity at 16
and 52 weeks, when compared to placebo with TCS.
"This is the first long-term Phase 3 data that demonstrated
dupilumab with topical corticosteroids was superior to topical
corticosteroids alone, and provided sustained efficacy,
significantly improving measures of overall disease severity, skin
clearing, itching, and quality of life through one year of
treatment," said George D.
Yancopoulos, M.D., Ph.D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories. "Although
topical corticosteroids are standard therapies for atopic
dermatitis, they are non-specific anti-inflammatory agents, while
dupilumab is a targeted therapy that specifically blocks the
IL-4/IL-13 signaling pathway. Our collective clinical data
demonstrate that this pathway is a root cause in atopic dermatitis,
asthma and nasal polyposis and we continue to evaluate the
potential of this pathway in these atopic and allergic
diseases."
"Dupilumab is an innovative first-in-class investigational agent
that has shown significant efficacy and a favorable safety profile
in two pivotal Phase 3 studies in monotherapy for
moderate-to-severe atopic dermatitis, and now in concomitant
administration with topical corticosteroids," said Elias Zerhouni, M.D., President, Global R&D,
Sanofi. "These one-year data strengthen the earlier 16-week
results, suggesting that dupilumab impacts the aberrant activation
of the IL-4/IL-13 pathway which resulted in significant efficacy
without the side effects associated with immune-suppressing
therapies. We will continue to advance dupilumab for patients
worldwide suffering from inadequately controlled moderate-to-severe
atopic dermatitis, with the first submission planned in the U.S.
for the third quarter of this year."
The primary endpoint results at week 16 were the following:
- 39 percent of patients who received either dupilumab 300 mg
weekly with TCS or dupilumab 300 mg every two weeks with TCS
achieved clearing or near-clearing of skin lesions (IGA 0 or 1),
compared to 12 percent of patients receiving placebo with TCS (p
less than 0.0001).
- 64 percent of patients who received dupilumab 300 mg weekly
with TCS, and 69 percent of patients who received dupilumab 300 mg
every two weeks with TCS achieved EASI-75, a 75 percent reduction
on an index measuring eczema severity, compared to 23 percent of
patients receiving placebo with TCS (p less than 0.0001).
The secondary endpoint 52-week results were the following:
- 40 percent of patients who received dupilumab 300 mg weekly
with TCS, and 36 percent of patients who received dupilumab 300 mg
every two weeks with TCS achieved clearing or near-clearing of skin
lesions (IGA 0 or 1), compared to 12.5 percent of patients
receiving placebo with TCS (p less than 0.0001).
- 64 percent of patients who received 300 mg weekly with TCS, and
65 percent of patients who received 300 mg every two weeks with TCS
achieved EASI-75, compared to 22 percent with placebo with TCS (p
less than 0.0001).
Patients were less likely to discontinue therapy in the
dupilumab with TCS groups compared to placebo with TCS group (15
percent in both dupilumab groups; 33 percent placebo).
The overall rate of adverse events was comparable between the
dupilumab with TCS groups (83 percent for the weekly dose (qw) and
88 percent for the every two weeks (q2w) dosing group) and the
placebo with TCS group (84 percent). The rate of serious adverse
events was comparable between the dupilumab with TCS groups (3 (qw)
and 4 percent (q2w)) and placebo with TCS group (5 percent).
Serious and/or severe infections were numerically higher in the
placebo with TCS group (1 percent in both dupilumab groups and 2
percent placebo). Adverse events that were noted to have a higher
rate with dupilumab included injection site reactions (20 (qw) and
16 percent (q2w) dupilumab; 9 percent placebo) and conjunctivitis
(19 (qw) and 13 (q2w) percent dupilumab; 8 percent placebo); 22
percent of patients on placebo, and 23 (qw) and 28 percent (q2w) of
patients on dupilumab reported a history of allergic conjunctivitis
at study entry.
More detailed results, including long-term efficacy and safety
data from CHRONOS will be submitted for presentation at a future
medical congress.
The U.S. Food and Drug Administration (FDA) granted dupilumab
Breakthrough Therapy designation in AD in November 2014. Dupilumab is currently under
clinical development and its safety and efficacy have not been
fully evaluated by any regulatory authority. If approved, dupilumab
would be commercialized by Regeneron and Sanofi Genzyme, the
specialty care global business of Sanofi.
The LIBERTY AD Phase 3 clinical program consists of five trials
of patients with moderate-to-severe AD at sites worldwide.
About the LIBERTY AD CHRONOS TRIAL
A total of 740 adult patients with moderate-to-severe AD were
enrolled in CHRONOS. All patients were inadequately controlled with
topical medications and were assessed via the 5-point
Investigator's Global Assessment (IGA) scale, ranging from 0
(clear) to 4 (severe); entry criteria required a baseline score of
3 or 4. Patients were also assessed using the Eczema Area and
Severity Index (EASI) and other measures. All patients initiated
daily treatment with a medium potency TCS or low potency TCS on
areas of the body where medium potency TCS is considered unsafe.
Patients were randomized in a 3:1:3 fashion into the following
treatment groups (all in combination with TCS): dupilumab 300 mg
subcutaneously once per week (n=319), dupilumab 300 mg
subcutaneously every two weeks (n=106), or placebo (n=315). This
design allowed sufficient power for the efficacy endpoints in both
dupilumab groups while increasing the available safety data on the
more frequent dosing regimen. In the U.S., the primary efficacy
endpoint of the study was the percent of patients who achieved IGA
0 or 1 at 16 weeks. In Europe and
Japan there was an additional
co-primary endpoint: the percent of patients achieving an EASI 75
score at week 16. The primary analysis was pre-specified to
occur 52 weeks after approximately 85 percent of patients were
randomized into the study.
About Atopic Dermatitis
Atopic dermatitis – a serious
form of eczema – is a chronic inflammatory disease characterized by
itchy, inflamed skin that can be present on any part of the
body. Though symptoms appear externally, atopic dermatitis is
characterized by underlying inflammation. About 70 percent of
people with atopic dermatitis have a family history of other common
atopic diseases, such as asthma or hay fever. In many cases, atopic
dermatitis is characterized by pruritus (itchiness) and skin
lesions. The intense itching, scratching and skin damage associated
with the disease can cause secondary infections that may require
additional treatments. In addition, the physical manifestations of
the disease can lead to anxiety, depression, and feelings of social
isolation. Based on a survey of 200 physicians, there are
approximately 1.6 million patients in the U.S. that have been
diagnosed with moderate-to-severe atopic dermatitis, and are
currently being treated but still are living with inadequately
controlled disease.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in diabetes
solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in
Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
based in Tarrytown, New York that
discovers, invents, develops, manufactures, and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for, eye diseases, high LDL
cholesterol and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including rheumatoid arthritis, asthma, atopic dermatitis,
pain, oncology, and infectious diseases. For additional information
about the company, please visit www.regeneron.com or follow
@Regeneron on Twitter.
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