Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced the
submission of a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15%
for the treatment of mild to moderate atopic dermatitis (AD) in
adults and children ages 6 years and older.
“Atopic dermatitis is a chronic and relapsing disease that
occurs across the lifespan. In clinical studies, once-daily
roflumilast cream provided rapid clearance of the disease. In
addition, roflumilast cream rapidly reduced itch, one of the most
bothersome symptoms to patients, in as little as twenty-four
hours,” said Eric Simpson, MD, MCR, FAAD, Professor of Dermatology
at Oregon Health & Science University in Portland, Oregon, and
investigator in the Phase 3 INTEGUMENT trials. “The INTEGUMENT
studies’ novel approach also incorporated assessment of twice
weekly proactive treatment in the long-term study, which
demonstrated that, once clear, patients could maintain adequate
control by staying ahead of the condition rather than chasing
flares. Together, these data suggest that roflumilast cream, if
approved, could provide a simplified approach to disease
control.”
Roflumilast cream is a once-daily, steroid-free, topical
formulation of a highly potent and selective phosphodiesterase-4
(PDE4) inhibitor. Roflumilast cream is uniquely formulated with
HydroARQ Technology™ as a non-greasy emollient cream that absorbs
quickly and does not disrupt the skin barrier. In addition,
roflumilast cream does not include sensitizing excipients or
irritants, such as propylene glycol, polyethylene glycol, isopropyl
alcohol, ethanol, or fragrances.
“Atopic dermatitis is a complex disease. Optimal management of
the condition requires a complex balance of treatment, efficacy,
safety, tolerability, as well as adherence. Atopic dermatitis
patients have sensitive skin and increased risk for developing
contact dermatitis from their topical medications,” said Jonathan
Silverberg, MD, PhD, MPH, FAAD, Professor, Director of Clinical
Research, and Director of Patch Testing at George Washington
University School of Medicine and Health Sciences, Washington, DC.
“Topical roflumilast cream was intentionally formulated with the
atopic dermatitis patient in mind, and does not contain excipients
that disrupt skin-barrier integrity or are common contact
allergens. Overall, once-daily topical roflumilast cream has
demonstrated in clinical trials a balance of efficacy and
tolerability, along with a long-term safety profile, that could
support increased adherence for patients with atopic
dermatitis.”
“Topical therapies are foundational therapy for the vast
majority of individuals who use pharmaceuticals to treat their
atopic dermatitis, but today’s topicals come with limitations.
People suffering from atopic dermatitis want fast-acting,
steroid-free, topical treatments that are effective and well
tolerated,” said Frank Watanabe, President and Chief Executive
Officer of Arcutis. “This is particularly important given the
prevalence of the disease in children, where safety and
tolerability are of particularly great concern when considering
which treatment to use. Both healthcare professionals and patients
or parents deserve to feel confident in the treatment decisions
they make.”
“Today marks another critical milestone for Arcutis, with the
third topical roflumilast submission in two years. I would like to
thank the team at Arcutis for their incredible hard work and
dedication,” added Watanabe.About the Data The
sNDA submission is supported by positive results from the
“INterventional Trial EvaluatinG roflUMilast cream for the treatmENt
of aTopic dermatitis” (INTEGUMENT-1 and INTEGUMENT-2) trials; two
identical Phase 3, parallel group, double blind, vehicle-controlled
trials in which roflumilast cream 0.15% or vehicle was applied
once-daily for four weeks to individuals 6 years of age and older
with mild to moderate AD involving ≥3% body surface area.
Both studies met the primary endpoint of IGA Success, defined as
a validated Investigator Global Assessment – Atopic Dermatitis
(vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade
improvement from baseline at Week 4 (INTEGUMENT-1: 32.0%
roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2:
28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001).
Over 30% of individuals treated with roflumilast cream in each
study achieved Worst Itch-Numeric Rating Scale (WI-NRS) Success at
Week 4. WI-NRS Success is defined as achievement of at least a
4‑point reduction on the WI-NRS 0-10 scale (in individuals 12 and
older who had a baseline WI-NRS score of at least 4). Rapid and
significant improvement in itch was observed in individuals treated
with roflumilast cream compared with vehicle as early as 24 hours
following the first application, as measured by the least-squares
(LS) mean change from baseline in daily WI-NRS scores between the
two groups (nominal P<0.05).
In both studies, approximately 40% of children and adults
treated with roflumilast cream achieved a vIGA-AD score of Clear
(0) or Almost Clear (1) at Week 4 (INTEGUMENT-1: 41.5% vs. 25.2%,
P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001), with
significant improvement as early as Week 1 (P< 0.0001).
In addition, more than 40% of children and adults treated with
roflumilast cream achieved a 75% reduction in Eczema Area and
Severity Index (EASI-75) at Week 4 compared to vehicle
(INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0%
vs. 19.7%, P<0.0001). Significant improvements in EASI-75 were
observed with roflumilast cream as early as Week 1 in both studies
(nominal P=0.0006; nominal P=0.0329).
Roflumilast cream 0.15% was well tolerated. The incidence of
Treatment Emergent Adverse Events (TEAEs) was low in both active
treatment and vehicle arms, with most TEAEs assessed as mild to
moderate in severity. There were no adverse reactions in the
combined Phase 3 pivotal trials that occurred in more than 2.9% of
subjects in either arm. The most common adverse reactions included
headache (2.9%), nausea (1.9%), application site pain (1.5%),
diarrhea (1.5%), and vomiting (1.5%). The submission is also
supported by data from a Phase 2 dose ranging study, an open label
extension study in which patients were treated for up to 52 weeks,
and two Phase 1 pharmacokinetic studies.
About Atopic DermatitisAD is the most common
type of eczema, affecting approximately 9.6 million children and
16.5 million adults in the United States. AD is characterized by a
defect in the skin barrier, which allows allergens and other
irritants to enter the skin, leading to an immune reaction and
inflammation. This reaction produces a red, itchy rash, most
frequently occurring on the face, arms, and legs. The rash can
cover significant areas of the body, in some cases half of the body
or more. AD typically begins in early childhood and is chronic. It
persists into adolescence and even adulthood in some individuals.
The rash causes significant pruritus (itching), which can lead to
skin damage caused by scratching or rubbing. Since a large
percentage of AD patients are children, safety is a particularly
important consideration in treatment selection.
About Roflumilast Cream Roflumilast cream is a
next generation topical PDE4 inhibitor. PDE4 – an established
target in dermatology – is an intracellular enzyme that increases
the production of pro-inflammatory mediators and decreases
production of anti-inflammatory mediators. Roflumilast cream 0.3%
(ZORYVE®) is approved by the FDA for the topical treatment of
plaque psoriasis, including intertriginous areas, in patients 12
years of age and older. Roflumilast cream for AD was evaluated at
lower doses than the approved psoriasis dose: 0.15% for adults and
children 6 years of age and older and 0.05% for children aged 2 to
5 years.
About ZORYVEZORYVE (roflumilast) cream 0.3% is
indicated for topical treatment of plaque psoriasis, including
intertriginous areas, in patients 12 years of age and older.
IMPORTANT SAFETY INFORMATIONThe use of ZORYVE
is contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions in psoriasis subjects (≥1%)
include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea
(1.2%), application site pain (1.0%), upper respiratory tract
infection (1.0%), and urinary tract infection (1.0%).
Please see full Prescribing Information.
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is an early commercial-stage medical dermatology
company that champions meaningful innovation to address the urgent
needs of individuals living with immune-mediated dermatological
diseases and conditions. With a commitment to solving the most
persistent patient challenges in dermatology, Arcutis has a growing
portfolio that harnesses our unique dermatology development
platform coupled with our dermatology expertise to build
differentiated therapies against biologically validated targets.
Arcutis’ dermatology development platform includes a robust
pipeline with multiple clinical programs for a range of
inflammatory dermatological conditions including scalp and body
psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia
areata. For more information, visit www.arcutis.com or follow
Arcutis on LinkedIn, Facebook, and Twitter.
Forward-Looking StatementsArcutis cautions you
that statements contained in this press release regarding matters
that are not historical facts are forward-looking statements. These
statements are based on the Company’s current beliefs and
expectations. Such forward-looking statements include, among
others, statements regarding the potential for roflumilast to be
approved for the treatment of adults and children with AD, the
potential to use roflumilast cream over a long period of time, or
chronically, the potential to use roflumilast cream anywhere on the
body, including the face and sensitive areas, the potential for
roflumilast to advance the standard of care in AD and other
inflammatory dermatologic conditions. These statements are subject
to substantial known and unknown risks, uncertainties and other
factors that may cause our actual results, levels of activity,
performance, or achievements to be materially different from the
information expressed or implied by these forward-looking
statements. Risks and uncertainties that may cause our actual
results to differ include risks inherent in our business,
reimbursement and access to our products, the impact of competition
and other important factors discussed in the “Risk Factors” section
of our Form 10-K filed with U.S. Securities and Exchange Commission
(SEC) on February 28, 2023, as well as any subsequent filings with
the SEC. You should not place undue reliance on any forward-looking
statements in this press release. We undertake no obligation to
revise or update information herein to reflect events or
circumstances in the future, even if new information becomes
available. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
Contacts:MediaAmanda Sheldon, Head of Corporate
Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@arcutis.com
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