Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced new
individual patient response data showing the vast majority of
individuals (91.5%) treated with investigational roflumilast cream
0.15% had a measurable improvement in Eczema Area and Severity
Index (EASI) in 4 weeks. New pooled analyses from two pivotal Phase
3 studies (INTEGUMENT-1 and INTEGUMENT-2) were presented at the
2024 Winter Clinical Dermatology Conference – Hawaii held January
12-17, 2024, in Honolulu, HI. Roflumilast cream 0.15% is a
once-daily, steroid-free cream being investigated for adults and
children 6 years of age and older with atopic dermatitis.
At Week 4, a statistically significant greater percentage of
patients achieved a 50% reduction in EASI scores (EASI-50), with
69.2% of patients treated with roflumilast cream compared to 44.4%
of those treated with vehicle (p<0.0001) based on observed data.
At the same 4-week endpoint, a 75% reduction in EASI scores
(EASI-75) was achieved in 44.5% of roflumilast-treated patients
compared to 21.2% of vehicle-treated patients (p<0.0001).
Importantly, EASI-90 was observed in 22.4% of patients treated with
roflumilast cream compared to 8.6% of vehicle-treated patients
(p<0.0001) and a 100% reduction (EASI-100) was observed in 9.8%
of patients treated with roflumilast cream compared to 4.8% of
vehicle-treated patients (p<0.002).
“These individual patient response data can give confidence to
clinicians that roflumilast cream can provide predictable and
effective improvement of atopic dermatitis, with 70% of adults and
children achieving EASI-50 and nearly one in four achieving 90% or
greater improvement in eczema area and severity. If approved, the
consistent efficacy with daily application over a four week period
combined with a tolerability and safety profile without limitations
on body regions or duration treated will make this a great addition
for management of pediatric and adult atopic dermatitis,” said
Lawrence Eichenfield, MD, chief of pediatric and adolescent
dermatology at Rady Children's Hospital-San Diego, professor of
dermatology and pediatrics and vice-chair of the department of
dermatology at UC San Diego School of Medicine, and study
investigator.
“These data demonstrate the rapid and reliable efficacy of
roflumilast cream in atopic dermatitis with the majority of
individuals achieving measurable improvement in EASI in as little
as one week,” said Patrick Burnett, MD, PhD, FAAD, chief medical
officer of Arcutis. “We are pleased to be able to share these
individual response data with the wider dermatology community and
develop a better understanding about the consistent clinical
response to roflumilast cream for patients with atopic
dermatitis.”
Roflumilast cream 0.15% safety and tolerability data were
comparable with vehicle, with low rates of application site adverse
events (AEs), treatment-related AEs, and discontinuations due to
AEs. The most common adverse reactions included headache (2.9%),
nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and
vomiting (1.5%).
INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial
EvaluatinG roflUMilast cream for the treatmENt of aTopic
dermatitis) were two identical Phase 3, parallel group, double
blind, vehicle-controlled trials evaluating the safety and efficacy
of roflumilast cream 0.15% in AD.
Poster DetailsRoflumilast Cream 0.15% in
Patients With Atopic Dermatitis: Individual Patient EASI
Responses: Pooled INTEGUMENT 1 and INTEGUMENT 2 Phase 3
TrialsSimpson, E et al.
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. It 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, and in some cases
covers half of the body or more.
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.
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 0.3% 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, 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 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 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
InvestorsDerek ColeInvestor Relations Advisory
Solutionsderek.cole@iradvisory.com
Arcutis Biotherapeutics (NASDAQ:ARQT)
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Arcutis Biotherapeutics (NASDAQ:ARQT)
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