Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), a commercial-stage
biopharmaceutical company focused on developing meaningful
innovations in immuno-dermatology, today announced results from the
INTEGUMENT-OLE long-term open-label study of once-daily roflumilast
cream 0.05% demonstrating the durable efficacy and favorable safety
profile of roflumilast cream 0.05% in the treatment of mild to
moderate AD in children 2 to 5 years old. In the study, roflumilast
cream was well-tolerated, with no new safety signals observed
during treatment of up to 56 weeks in duration. Efficacy was not
only maintained but improved over time, with 71.9% of participants
who rolled over from the roflumilast cream 0.05% treatment arm in
INTEGUMENT-PED achieving 75% improvement from baseline in Eczema
Area and Severity Index (EASI-75) after 56 weeks.
“When choosing a therapy for very young children, health care
providers and caregivers are looking for treatments that provide
both rapid relief and are well-tolerated and suitable for long-term
use,” said Adelaide Hebert, MD, professor of dermatology and
pediatrics at UTHealth Houston, and INTEGUMENT trial
investigator. “These results build upon the findings from the
Phase 3 trial of roflumilast cream 0.05% that demonstrated rapid
efficacy within the first 4 weeks of treatment, and further showed
long-term durable efficacy and tolerability of investigational
roflumilast cream, with continued improvement over the course of
the long-term study.”
In the study, 53.8% of participants who rolled over from the
roflumilast cream treatment arm in INTEGUMENT-PED achieved a
validated Investigator Global Assessment-Atopic Dermatitis
(vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a
2-grade improvement from baseline, at 56 weeks.
The long-term study results reinforce the safety and
tolerability profile of roflumilast cream 0.05% already seen in the
4-week pivotal INTEGUMENT-PED clinical trial, with no new safety
signals observed up to 56 weeks. Overall incidence of adverse
events was low, with most being mild to moderate in nature. The
most frequently reported adverse events (≥3%) included: upper
respiratory tract infection, nasopharyngitis, pyrexia, influenza,
COVID-19, and otitis media. Overall, only 3.0% of trial
participants discontinued the study due to adverse events.
“Roflumilast cream is uniquely formulated with the AD patient in
mind, to deliver treatment without sensitizing excipients and
irritants, which can often disrupt the skin barrier. We are excited
by these results, which reinforce the strength of our ZORYVE
product portfolio and specifically demonstrate the long-term
efficacy, safety and tolerability profile of our once-daily
roflumilast cream for the treatment of pediatric AD,” said Patrick
Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Based on
these positive results, we are convinced that, if approved,
roflumilast cream 0.05% can help provide immediate as well as
long-term management of this burdensome skin condition, expanding
the treatment population to children down to age 2.”
Arcutis intends to submit an sNDA to the FDA in the first
quarter of 2025 for roflumilast cream 0.05% for the treatment of AD
in individuals ages 2-5 years. ZORYVE® (roflumilast) cream 0.15% is
approved for the topical treatment of mild to moderate AD in adults
and pediatric patients down to age 6.
About INTEGUMENT-OLEThe “INterventional Trial
EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis
Open Label Extension (INTEGUMENT-OLE) was a Phase 3, multicenter,
open-label extension study of the long-term safety of roflumilast
cream 0.15% in adults and children ages 6 years and older with AD
and roflumilast cream 0.05% in children ages 2 to 5 years. A total
of 562 individuals enrolled in the study after completing the
INTEGUMENT-PED Phase 3 trial.
The study evaluated monotherapy with roflumilast cream 0.05%
with no rescue treatment permitted. Beginning at Week 4 of
INTEGUMENT-OLE, any participant who achieved vIGA-AD of ‘0-Clear’
switched to twice weekly maintenance treatment. Participants were
able to continue twice weekly maintenance dosing, as long as
vIGA-AD remained either ‘0‑Clear’ or ‘1-Almost Clear’. Participants
resumed once-daily dosing if vIGA-AD reached ≥2-Mild, and could
also resume once-daily dosing if signs/symptoms of AD were not
adequately controlled with maintenance therapy.
The primary objective of the study was to assess the long-term
safety of roflumilast cream. Secondary endpoints included vIGA-AD
score of 0 or 1 at each assessment, vIGA-AD success defined as
vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline,
and Eczema Area and Severity Index (EASI) score over time. The
assessment of vIGA-AD Success and EASI-75 response, as reported
here, references baseline of INTEGUMENT-PED.
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-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 FDA for the topical
treatment of plaque psoriasis, including intertriginous areas, in
patients 6 years of age and older. Roflumilast cream 0.15%
(ZORYVE®) is approved by the U.S. Food and Drug Administration
(FDA) for the topical treatment of mild to moderate atopic
dermatitis, in patients 6 years of age and older. A lower dose,
roflumilast cream 0.05%, was evaluated for children aged 2 to 5
years.
INDICATIONSZORYVE cream, 0.3%, is indicated for
topical treatment of plaque psoriasis, including intertriginous
areas, in adult and pediatric patients 6 years of age and
older.
ZORYVE cream, 0.15%, is indicated for topical treatment of mild
to moderate atopic dermatitis in adult and pediatric 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%) for ZORYVE cream 0.3%
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%).
The most common adverse reactions (≥1%) for ZORYVE cream 0.15%
for atopic dermatitis include headache (2.9%), nausea (1.9%),
application site pain (1.5%), diarrhea (1.5%), and vomiting
(1.5%).
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 three 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, AD. and alopecia areata. For more information,
visit www.arcutis.com or follow Arcutis on LinkedIn,
Facebook, Instagram, 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
children ages 2 to 5 with AD, the potential to use roflumilast
cream in those ages 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
AD 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, and 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 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 Communicationsmedia@arcutis.com
InvestorsLatha Vairavan, Vice President,
Finance and Corporate Controllerir@arcutis.com
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