Arcutis Announces Acceptance of Late Breaking Abstract in Atopic Dermatitis Among Five New Topical Roflumilast Data Being Presented at the American Academy of Dermatology Annual Meeting
04 3월 2024 - 10:00PM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced five
presentations at the 2024 American Academy of Dermatology (AAD)
annual meeting, which will take place in San Diego, CA from March 8
- 12, 2024. Among these presentations will be late-breaking
clinical data on roflumilast cream 0.05% in patients 2 to 5 years
of age with mild to moderate atopic dermatitis from the pivotal
INTEGUMENT-PED Phase 3 randomized controlled trial.
“Our significant presence at this year’s AAD is a
testament to our commitment to bringing meaningful innovation in
immuno-dermatology, and building on the body of evidence supporting
our topical roflumilast development program. In particular, we are
excited to be participating in the late breaking data presentations
with new results from INTEGUMENT-PED, as part of our atopic
dermatitis clinical program,” said Patrick Burnett, MD, PhD, FAAD,
chief medical officer, Arcutis. “We appreciate the opportunity to
participate in the AAD and other medical meetings to engage with
our peers and progress the medical dermatology field.”
Presentation details follow:
- Late Breaking Data PresentationEfficacy and Safety of
Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5
Years of Age With Mild to Moderate Atopic Dermatitis
(INTEGUMENT-PED): A Phase 3 Randomized Controlled
TrialPresenting Author: Dr. Lawrence EichenfieldTime:
March 10, 2024, 2:30 PM PTRoom: 20BCD
- Oral Poster PresentationRoflumilast Cream 0.3% in
Patients With Psoriasis: Improvement in Patient Reported Outcomes
and Pruritus From Two Pooled Phase 3 Trials
(DERMIS-1/DERMIS-2)Presenting Author: Dr. Mark
LebwohlTime: March 9, 2024, 3:25 PM PTRoom: Upper Level, Sails
Pavilion, Poster Center 2
The following posters will be electronically available for the
entirety of the conference and online beginning Friday, March 8,
2024:
Pooled
Efficacy, Patient-Reported Outcomes, and Safety of Roflumilast
Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Clinical
Trials of Adults and Children With Atopic Dermatitis
Simpson, E et al. ePoster 53863
Roflumilast
Foam 0.3% Once Daily in Patients With Seborrheic Dermatitis:
Improvement in Patient Reported Outcomes and Pruritus From a Phase
3 Trial (STRATUM)Bhatia, N et al.ePoster 53894
Patient-Reported Outcomes With Roflumilast Foam 0.3% in
Patients With Scalp and Body Psoriasis in the Phase 3 ARRECTOR
TrialGooderham, M et al.ePoster 53817
Roflumilast
Cream 0.3% in Patients With Psoriasis: Improvement in Patient
Reported Outcomes and Pruritus From Two Pooled Phase 3 Trials
(DERMIS-1/DERMIS-2)Lebwohl, M et al.ePoster 53025
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.
INDICATIONS ZORYVE cream is
indicated for topical treatment of plaque psoriasis, including
intertriginous areas, in patients 6 years of age and older.
ZORYVE foam, 0.3%, is indicated for treatment of
seborrheic dermatitis in adult and pediatric patients 9 years
of age and older.
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are
flammable. Avoid fire, flame, and smoking during and immediately
following application.
The most common adverse reactions (≥1%) for ZORYVE
cream 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
foam include nasopharyngitis (1.5%), nausea (1.3%), and headache
(1.1%).
Please see full Prescribing Information for ZORYVE
foam and full Prescribing Information for ZORYVE cream.
Forward-Looking Statements
Arcutis 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 for topical roflumilast to advance the standard of
care in 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: Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com
Investors Latha Vairavan, Vice
President, Finance and Investor Relations lvairavan@arcutis.com
Derek Cole Investor Relations Advisory Solutions
derek.cole@iradvisory.com
Arcutis Biotherapeutics (NASDAQ:ARQT)
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