Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced new
results from the INTEGUMENT-OLE long-term open-label study of
investigational once-daily roflumilast cream 0.15% in adults and
children ages 6 years and older with AD presented at the
Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference.
In the study, roflumilast cream was well-tolerated, with no new
safety signals observed over 56 weeks of treatment. Efficacy was
not only maintained but improved over time, with 56.6% of
participants who continued use of roflumilast cream from the
initial trial and 53.8% of participants who switched to roflumilast
cream 0.15% from vehicle after the initial trial achieving
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 Week 56.
Starting at Week 4 of INTEGUMENT-OLE, participants who achieved
a vIGA-AD score of clear (0), switched to proactive twice-weekly
application (130 participants; 19.8% of study population). For
these participants, after their first switch to twice-weekly
application, the median duration of disease control (maintaining
vIGA-AD of 0 or 1 with adequate control of signs and symptoms on
the twice-weekly schedule application) was 281 days (95% CI: 147,
not evaluable). In addition, 57.7% of these participants maintained
disease control on the twice weekly schedule through their final
study day.
“AD is a chronic, burdensome skin condition that requires
clinicians and patients to seek a treatment option that can be
safely and effectively used long-term for an adult or child,” said
Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre
for Dermatology, investigator with Probity Medical Research, and
study presenter. “Importantly, investigational roflumilast cream
0.15% showed continued improvement through the course of the study,
demonstrating that once approved, roflumilast cream may be an
effective long-term, steroid-free treatment option that can be used
for proactive flare-free disease control. These results also
reinforce the durable efficacy and tolerability of roflumilast
cream in AD, which could translate to improved treatment
adherence.”
“Adults and children with AD deserve treatment standards that
focus on maintaining long-term disease control, rather than
reactively managing flares. This novel pivotal study design
evaluated proactive twice-weekly application with a targeted
topical treatment, and demonstrates that after achieving disease
clearance, patients can maintain disease control for at least 281
days,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor of
Dermatology and Immunology, Icahn School of Medicine at Mount
Sinai, chair of the Kimberly and Eric J. Waldman Department of
Dermatology, Mount Sinai Health System, and director of the
Laboratory for Inflammatory Skin Diseases at Mount
Sinai. “These results provide support for shifting the
paradigm from reactively chasing flares to long-term flare-free
disease management.” Dr. Guttman-Yassky is a paid consultant with
Arcutis Biotherapeutics.
Additional results presented include:
- 66.2% and 64.6% of participants who rolled over from the
roflumilast cream arm in INTEGUMENT-1 or -2 or switched to
once-daily roflumilast cream 0.15% from the vehicle arm
demonstrated a 75% improvement from baseline in EASI-75 after 56
weeks, respectively.
- 56.9% and 50.0% of participants who rolled over from or
switched to once-daily roflumilast cream 0.15% treatment achieved a
significant reduction (≥4-point) in itch based on daily Worst Itch
Numeric Rating Scale (WI-NRS) (among patients aged ≥12 years with
baseline WI-NRS ≥4) at Week 56, respectively.
These long-term study results provide further support for the
safety and tolerability profile of roflumilast cream already seen
in the pivotal INTEGUMENT-1 and INTEGUMENT-2 clinical trials, with
no new safety signals observed up to 56 weeks. Overall incidence of
adverse events was low, with most being mild to moderate in
severity. The most frequently reported adverse events (≥2%)
included: COVID-19, upper respiratory tract infection,
nasopharyngitis, and headache. Overall, only 3.0% of trial
participants discontinued the study due to adverse events.
“Investigational roflumilast cream 0.15% is designed to provide
clinicians and individuals with AD with a long-term treatment
option that is formulated free of known ingredients or allergens
that may disrupt and compromise skin barrier integrity,” said
Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis.
“Based on these positive results, individuals can expect long-term
efficacy and improvement in the signs and symptoms of AD, including
itch, from roflumilast cream. If approved, we believe that
roflumilast cream offers patients with AD an important steroid-free
topical option that can provide lasting symptom relief which is
maintained over time.”
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 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. Individuals completing the
INTEGUMENT-1 or INTEGUMENT-2 Phase 3 trials were eligible to enroll
(n=658) for either 24 or 52 weeks. Reported here are data from
adults and children down to age 6.
The study evaluated monotherapy with roflumilast cream 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 proactive treatment. Participants were able to
continue twice-weekly proactive 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 proactive therapy despite remaining at vIGA-AD of
‘1-Almost Clear’.
The primary objective of the study was to assess the long-term
safety of roflumilast cream after either 24 or 52 weeks of
treatment. Secondary endpoints include vIGA-AD score of 0 or 1 at
each assessment, vIGA-AD success, WI-NRS score over time, and EASI
score over time. The assessment of IGA Success and EASI-75
response, as reported here, references baseline of INTEGUMENT-1 and
-2.
About Atopic DermatitisThe most common type of
eczema, AD affects approximately 9.6 million children and 16.5
million adults in the United States. AD is a chronic, relapsing
inflammatory skin disease that is genetically pre-disposed and
presents across the lifespan. The disease appears as a red,
intensely itchy rash that can occur anywhere on the body and may
present differently in children and adults. AD presentation can
rapidly fluctuate and vary based on geographic location and
environment.
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 AD: 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%.
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 INFORMATIONZORYVE 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, 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 of roflumilast cream
to simplify disease management for care of AD; the potential of
real-world use results of roflumilast cream, as well as the
potential approval of roflumilast cream for AD. 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
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