Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today presented in a
late-breaking clinical trial session at the American Academy of
Dermatology (AAD) annual meeting (San Diego, CA, March 8 – 12) new
data from its INTEGUMENT-PED pivotal Phase 3 study of
investigational roflumilast cream 0.05% in children 2 to 5 years of
age with mild to moderate atopic dermatitis. The study found that
treatment with once-daily, steroid-free roflumilast cream 0.05%
resulted in significant improvements in atopic dermatitis across
multiple efficacy endpoints and all timepoints, including disease
clearance as early as Week 1 and reduction in itch in the first 24
hours following application.
Results showed 25.4% of children treated with roflumilast cream
0.05% achieved the primary endpoint of IGA Success, defined as
vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade
improvement from baseline at Week 4, compared to 10.7% treated with
the vehicle (P<0.0001), with significant improvements also seen
at Week 1 and Week 2. In the study, 39.4% of children treated with
roflumilast cream 0.05% achieved a 75% improvement in EASI
(EASI-75) at Week 4 compared to 20.6% treated with vehicle
(P<0.0001).
“For the pediatric patient population, tradeoffs between
efficacy, tolerability, and safety are critical aspects of atopic
dermatitis treatment decisions. In addition, tolerability is
paramount, and if there are problems with tolerability, there is a
hurdle for adherence,” said Lawrence F. Eichenfield, MD, professor
of dermatology and pediatrics and vice-chair of the department of
dermatology at UC San Diego School of Medicine, and study
investigator. “These tradeoffs are further amplified in young
children, which is why having a well-designed formulation that
doesn’t disrupt the skin barrier benefits the patient and decreases
the concerns of caregivers. The results from this study of
once-daily application of roflumilast cream 0.05% in patients 2 to
5 years old are consistent with the findings from the INTEGUMENT-1
and INTEGUMENT-2 studies of patients down to the age of 6. If
approved, this profile will be a welcome, easily adopted option for
patients and clinicians alike.”
Roflumilast cream is an investigational once-daily, steroid-free
topical cream formulated to deliver drug without disrupting the
skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5,
with a mean Body Surface Area of 22% overall, and a range from 3%
to 82%. The data reinforces the well-established efficacy, safety,
and tolerability profile of roflumilast cream in atopic dermatitis
across the INTEGUMENT program.
New data highlighted in the session included 35.4% of children
treated with roflumilast cream achieved vIGA-AD clear (0) or almost
clear (1) compared to 14.6% of vehicle (P<0.0001) at the end of
the study (Week 4), with improvements seen as early as Week 1. In
addition, the data show improvement in itch with roflumilast cream
0.05% as early as 24 hours following first application, based on LS
mean change from baseline in daily WI-NRS score (P=0.0014 vs
vehicle).
“We are pleased to present these data from our pivotal Phase 3
INTEGUMENT-PED study of roflumilast cream in children aged 2
through 5, which provide strong support for the safety and efficacy
in this young age group and are consistent with the results with
roflumilast cream across our atopic dermatitis development
program,” said Patrick Burnett, MD, PhD, FAAD, chief medical
officer, Arcutis. “Roflumilast cream 0.05% was also shown to be
well-tolerated in young children as demonstrated by both
investigator and patient-reported outcomes. We know that there is a
significant unmet need for safe, tolerable, and efficacious topical
treatments for this young patient population, and look forward to
providing meaningful innovation through the continued development
of roflumilast cream.”
Roflumilast cream 0.05% was well tolerated. The incidence of
Treatment Emergent Adverse Events (TEAEs) was low, and the only
adverse event occurring in ≥3% of subjects in either active- or
vehicle-arm was upper respiratory tract infection. The most
frequent adverse events in the roflumilast arm (≥2%) included
pyrexia, diarrhea, and vomiting. Local tolerability was also
favorable, with application site pain only being reported in 1.6%
of roflumilast-treated participants vs.1.9% for the vehicle.
About INTEGUMENT-PED
The “INterventional Trial
EvaluatinG
roflUMilast cream for the
treatmENt of aTopic dermatitis in
PEDiatric patients” (INTEGUMENT-PED) was 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 atopic
dermatitis. No moisturizers, emollients, or other products were
allowed on treatment sites during the trial. 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 attained at least a 75% reduction in the EASI-75 at
Week 4.
About Roflumilast CreamRoflumilast cream is a
next generation topical phosphodiesterase-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 0.3% (ZORYVE®) is approved by the Food and Drug
Administration (FDA) for the topical treatment of plaque psoriasis,
including intertriginous areas, in patients 6 years of age and
older. Investigational roflumilast cream was evaluated at lower
doses for atopic dermatitis: 0.15% for adults and children 6 years
of age and older and 0.05% for children aged 2 to 5 years.
Roflumilast cream 0.15% is under review at the FDA for the
treatment of adults and children 6 years of age and older with a
Prescription Drug User Fee Act (PDUFA) target action date of July
07, 2024. Arcutis intends to submit a supplemental new drug
application (sNDA) for roflumilast cream 0.05% in ages 2 to 5
following the potential approval of roflumilast cream
0.15%.Roflumilast cream is uniquely formulated 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.
About ZORYVE®
CreamZORYVE (roflumilast) cream is indicated for
topical treatment of plaque psoriasis, including intertriginous
areas, in patients 6 years of age and older.
IMPORTANT SAFETY INFORMATION ZORYVE is
contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) include diarrhea (3.1%),
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 a 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
including two FDA approved products that harness 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, 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 of
real-world use results of roflumilast cream, 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 U.S. Securities and
Exchange Commission (SEC) on February 27, 2024, 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
InvestorsLatha Vairavan, Vice President,
Finance and Investor Relationslvairavan@arcutis.com
Derek ColeInvestor Relations Advisory
Solutionsderek.cole@iradvisory.com
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