Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced that
the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream
0.05%, in children ages 2 to 5 years with mild to moderate atopic
dermatitis (AD) met its primary endpoint and all secondary
endpoints. In the study, 25.4% of children treated with roflumilast
cream 0.05% achieved 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, compared to 10.7% treated with vehicle
(P<0.0001), with significant improvements seen as early as Week
1.Roflumilast cream 0.05% is a once-daily steroid-free topical
cream in development, that is formulated to deliver drug without
disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children
ages 2 to 5, with a mean Body Surface Area (BSA) of 22% overall,
and a range from 3% to 82%. The data reinforce the well-established
efficacy, safety and tolerability profile of roflumilast cream in
atopic dermatitis across the INTEGUMENT program.
“Pediatric atopic dermatitis is a chronic, recurrent
inflammatory skin condition that can negatively impact
the quality of life of the child and family or
caregivers. Children’s skin is uniquely sensitive and finding
tolerable therapy is often more challenging. Ideally, sensitive
areas such as the face and eyelids need a topical treatment
that minimizes stinging and burning and is suitable for
long-term use,” said Adelaide A. Hebert, MD, Chief of
Pediatric Dermatology at McGovern Medical School at
UTHealth Houston, and INTEGUMENT-PED investigator. “The
positive findings from this study of roflumilast
cream are highly consistent with the findings from the
INTEGUMENT-1 and INTEGUMENT-2 studies. These results further
reinforce the safety and efficacy profile of roflumilast cream as a
potential treatment option, if approved, for pediatric atopic
dermatitis down to 2 years of age.”Roflumilast cream met all
secondary endpoints, with significant improvements seen across all
time points including vIGA-AD success and vIGA-AD of ‘clear’ and
‘almost clear’ at Week 1. In the study, 39.4% of children treated
with roflumilast cream 0.05% achieved a 75% improvement in EASI-75
at Week 4 compared to 20.6% treated with vehicle (P<0.0001). In
addition, 35.3% of children treated with roflumilast cream achieved
a four-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week
4 (vs. 18.0% for vehicle-treated subjects [nominal P=0.0002]).
“Atopic dermatitis is a chronic disease that is unstable in its
course. EASI-75 has emerged as an important endpoint in clinical
trials and reflects clinically meaningful responses in the real
world. EASI incorporates body surface area, and higher body surface
area involvement is an important consideration for the severity and
impact of the disease for patients suffering from pediatric atopic
dermatitis,” 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.
Roflumilast cream was very well-tolerated. Overall, the
incidence of adverse events in INTEGUMENT-PED was low, and the only
adverse event occurring in ≥3% of subjects in either arm was upper
respiratory tract infection. The most frequent adverse events in
the roflumilast arm (≥2%) included upper respiratory tract
infection, pyrexia, diarrhea, and vomiting. Of children who were
randomized to roflumilast cream in the study, 93.8% completed the
full four weeks, and there were few discontinuations due to adverse
events (1.1% and 1.9% in the roflumilast cream and vehicle groups,
respectively). Of the children who completed INTEGUMENT-PED, 93.4%
elected to continue open label, long-term treatment in the
INTEGUMENT-OLE study.
“Roflumilast cream was formulated with the atopic dermatitis
patient in mind, delivering drug without disrupting the skin
barrier or the use of sensitizing excipients and irritants. The
consistent safety and tolerability profile of roflumilast cream
sets our next generation PDE4 inhibitor apart,” said Patrick
Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “In
addition, roflumilast cream provided rapid improvement and control
in atopic dermatitis as well as quick reduction of itch, which
provides the positive feedback loop to the parent and caregiver
that the treatment is working and an incentive to maintain therapy
over time.”
The Company recently 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 in adults and children ages 6
years and older. Following the potential approval of roflumilast
cream 0.15% and based on these positive results, Arcutis intends to
submit an sNDA for roflumilast cream 0.05% for the treatment of
mild to moderate atopic dermatitis in children ages 2 to 5
years.
The Company will host a conference call to discuss the results
of both INTEGUMENT-PED and INTEGUMENT-OLE today at 8:30 a.m. ET. A
live webcast of the call and the presentation material will be
available on the “Events” section of the Company’s investor
website. An archived replay of the webcast will be available on the
Arcutis investor website following the conference.
About INTEGUMENT-PEDThe “INterventional Trial
EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis
in PEDiatric patients” (INTEGUMENT-PED) is a Phase 3, parallel
group, double blind, vehicle-controlled trial in which roflumilast
cream 0.05% or vehicle was applied once daily for four weeks to
children 2 to 5 years of age with mild to moderate AD. A total of
652 children were enrolled in the study. The primary endpoint was
IGA Success, defined as a vIGA-AD score of ‘clear’ or ‘almost
clear’ plus a 2-grade improvement from baseline at Week 4. Multiple
secondary endpoints were also evaluated, including the proportion
of subjects who attain at least a 75% reduction in the EASI-75 at
Week 4.
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 very young children, safety is a
particularly important consideration in treatment selection.
About Roflumilast CreamRoflumilast cream is a
next generation topical phosphodiesterase type 4 (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 is uniquely formulated as a non-greasy emollient
cream that absorbs quickly and spreads easily. In addition,
roflumilast cream does not include sensitizing excipients or
irritants such as propylene glycol, polyethylene glycol, isopropyl
alcohol, ethanol, or fragrances.
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: 0.15% for adults and children 6
years of age and older and is being evaluated at 0.05% for children
aged 2 to 5 years.
About ZORYVE®ZORYVE
(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 INFORMATION The use of ZORYVE
is contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) include diarrhea (3%),
headache (2%), insomnia (1%), nausea (1%), application site pain
(1%), upper respiratory tract infection (1%), and urinary tract
infection (1%).
Please see full Prescribing Information.
ZORYVE is for topical use only and not for ophthalmic, oral, or
intervaginal use.
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 X.
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, but are not
limited to, statements regarding the potential and timing for
roflumilast cream to be approved by the FDA for the treatment of
adults and children with atopic dermatitis, the potential to use
roflumilast cream over a long period of time, or chronically, the
potential to use roflumilast cream anywhere on the body, and the
potential for roflumilast cream to advance the standard of care in
atopic dermatitis and other inflammatory dermatological 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 the 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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