Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced
interim results from the INTEGUMENT-OLE long-term open-label study
of roflumilast cream 0.15% in adults and children ages 6 years and
older with atopic dermatitis. In the study, roflumilast cream was
well-tolerated, with no new safety signals observed during
treatment up to 56 weeks in duration. Efficacy was not only
maintained but improved over time, with 46.1% and 51.0% of
participants who rolled over from the roflumilast cream treatment
arm in INTEGUMENT-1 or -2 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 Weeks
28 and 56, respectively.
Starting at Week 4 of INTEGUMENT-OLE, participants who achieved
a vIGA-AD score of clear (0) switched to twice weekly maintenance
dosing. Participants were to resume once-daily dosing if vIGA-AD
reached mild (2) or if signs or symptoms were not adequately
controlled. Over two-thirds of participants who switched to
maintenance dosing remained on the twice weekly schedule for more
than half of their time in the study (post-Week 4).
“When determining a treatment plan for an adult or child with a
chronic, burdensome skin condition such as atopic dermatitis,
long-term efficacy and safety are both incredibly important
considerations,” said Eric Simpson, MD, MCR, FAAD, Professor of
Dermatology at Oregon Health & Science University in Portland,
Oregon, and INTEGUMENT trial investigator. “These results build
upon the positive findings from the pivotal Phase 3 trials of
roflumilast cream 0.15% in atopic dermatitis demonstrating rapid
efficacy within the first 4 weeks of treatment, and further
validate the long-term durable efficacy and tolerability of
roflumilast cream, with continued improvement over the course of
the long-term study. Importantly, individuals who reached clear
were able to switch to a twice weekly dosing and maintain control
of their disease through this schedule.”
“The goal and greatest clinical challenge for treating adults
and children with atopic dermatitis is dependable disease control.
Due to the instability of this chronic disease, long-term control
and safety is key; however, data on prevention and maintenance with
topical therapy is lacking. This long-term study was designed to
study proactive treatment, for patients with clear skin, to
optimize and maintain control with twice weekly dosing,” said Emma
Guttman-Yassky, MD, PhD, System Chair of the Department of
Dermatology and Waldman Professor of Dermatology and Immunology at
the Icahn School of Medicine at Mount Sinai. “These study
results provide evidence for a paradigm shift to break the cycle of
the current topical paradigm that only reactively chase and manage
flares, showing the utility of infrequent preventive treatment
regimens to disease control.” Dr. Guttman is a paid consultant with
Arcutis Biotherapeutics, Inc.
Additionally, in the study, 61.5% and 66.2% of participants who
rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2
demonstrated a 75% improvement from baseline in Eczema Area and
Severity Index (EASI-75) after 28 weeks and 56 weeks,
respectively.
The long-term study results reinforce the safety profile of
roflumilast cream already seen in the short-term 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 nature. 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.
“Roflumilast cream is uniquely formulated to deliver treatment
without sensitizing excipients and irritants, which can often
disrupt the skin barrier. We are excited by these results, which
demonstrate the long-term efficacy and the safety and tolerability
profile of our next generation phosphodiesterase type 4 (PDE4)
inhibitor for the treatment of atopic dermatitis,” said Patrick
Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Based on
the positive results we have seen, we are convinced that, if
approved, roflumilast cream will provide individuals with atopic
dermatitis with an important new long-term treatment option that is
designed with their specific needs in mind.”
Arcutis intends to submit a supplemental New Drug Application
(sNDA) late in the third quarter of 2023 for roflumilast cream
0.15% for the treatment of mild to moderate atopic dermatitis in
individuals ages 6 years and older.
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
atopic dermatitis 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.
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 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 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 defined as vIGA-AD value of 0 or 1
plus a 2-grade improvement from baseline, Worst Itch Numeric Scale
(WI-NRS) score over time, and Eczema Area and Severity Index (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 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 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 U.S. Food and Drug Administration
(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.
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, 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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