Arcutis Biotherapeutics to Present New Data from ARQ-151 (Topical Roflumilast Cream) Clinical Program at Three Global Dermato...
October 29 2020 - 9:07PM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing and commercializing
treatments for unmet needs in immune-mediated dermatological
diseases and conditions, or immuno-dermatology, today announced it
will present new data from the previously announced Phase 2 studies
of ARQ-151 (topical roflumilast cream) in chronic plaque psoriasis
and atopic dermatitis at the European Academy of Dermatology and
Venereology (EADV) Virtual Congress (EADV Virtual), the Society of
Dermatology Physician Assistants (SPDA) Digital 2020 conference,
and the virtual 2020 Fall Clinical Dermatology Conference.
“Results from our ongoing clinical development program highlight
the clinical benefit of roflumilast cream across multiple outcome
measures associated with the treatment of atopic dermatitis and
plaque psoriasis,” said Patrick Burnett, M.D., Ph.D., FAAD,
Arcutis’ Chief Medical Officer. “We are pleased to share these
significant new data with the medical community at each of this
week’s major conferences.”
At the EADV Virtual Congress, October 29-31, 2020, Arcutis will
present positive results from a Phase 2 proof-of-concept study on
the short-term safety and efficacy of roflumilast cream in patients
with mild-to-moderate atopic dermatitis. In addition, the company
will highlight data from a Phase 2b study on the impact of
roflumilast cream on itch, a highly prevalent and frequently
bothersome symptom of chronic plaque psoriasis, and symptom burden.
Details of Arcutis’ EADV Virtual Congress presentations
include:
- Oral Presentation (FC03.05): Roflumilast Cream
(ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in
Adults With Chronic Plaque Psoriasis in a Phase 2b
StudyDate: October 29, 2020
- Poster Presentation
(P1450): Roflumilast
Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults
With Chronic Plaque Psoriasis in a Phase 2b
StudyDate: October 29, 2020
- Oral Presentation (FC08.07): The Safety and
Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis:
Phase 2 Proof-of-Concept StudyDate: October 31,
2020
EADV Virtual poster sessions will be available for on-demand
viewing starting on October 29, 2020 and oral presentations (free
communication) will be available starting on the day of the
presentation.
2020 Fall Clinical Dermatology Conference
and Society of Dermatology Physician
Assistants (SDPA) DIGITAL 2020
Data presentations for roflumilast cream highlighted at the EADV
Virtual Congress have also been accepted as poster sessions that
will be available for on-demand viewing at the 2020 Fall Clinical
Dermatology Conference and SPDA DIGITAL 2020, both of which will
held virtually from October 29 – November 1, 2020.
The virtual presentations will be available for on-demand
viewing using the links below and under Scientific Publications on
the Arcutis website:
- Roflumilast Cream (ARQ-151) Improved Itch Severity and
Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in
a Phase 2b Study: EADV Virtual
Congress; 2020 Fall
Clinical; SPDA DIGITAL
2020
- Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom
Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study:
EADV Virtual Congress;
2020 Fall Clinical; SPDA
DIGITAL 2020
- The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in
Atopic Dermatitis: Phase 2 Proof-of-Concept Study: EADV
Virtual Congress; 2020 Fall
Clinical; SPDA DIGITAL
2020
About Atopic Dermatitis
Atopic dermatitis (AD) is the most common type of eczema,
occurring in approximately six percent of the U.S. population. 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,
and the rash can cover significant areas of the body, in some cases
half of the body or more. Disease onset is most common by 5 years
of age, and the Company estimates that approximately 60% of
patients suffering from AD are pediatric patients. The rash causes
significant pruritus (itching), which can lead to skin damage
caused by scratching or rubbing. Given that most of the patients
are pediatric, the safety and tolerability of AD therapies are
paramount.
About Psoriasis
Psoriasis is a common, non-contagious, immune-mediated skin
disease that affects approximately 8.6 million patients in the
United States. About 90% of patients develop plaque psoriasis,
which is characterized by raised, red areas of skin covered with a
silver or white layer of scale. Psoriatic plaques can appear on any
area of the body, but most often appear on the scalp, knees,
elbows, trunk, and limbs, and are often itchy and sometimes
painful. Plaques in certain anatomical areas present particular
treatment challenges, including the face, elbows and knees, scalp,
and intertriginous regions such as the groin, axillae and
inframammary areas.
About Arcutis - Bioscience, applied to the
skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage
biopharmaceutical company focused on developing and commercializing
treatments for unmet needs in immune-mediated dermatological
diseases and conditions, or immuno-dermatology. The company is
leveraging recent advances in immunology and inflammation to
develop differentiated therapies against biologically validated
targets to solve persistent treatment challenges in serious
diseases of the skin. Arcutis’ robust pipeline includes four novel
drug candidates currently in development for a range of
inflammatory dermatological conditions. The company’s lead product
candidate, topical roflumilast, has the potential to revitalize the
standard of care for plaque psoriasis, atopic dermatitis, scalp
psoriasis, and seborrheic dermatitis. For more information, visit
www.arcutis.com or follow the company on LinkedIn and Twitter.
Forward Looking Statements
This press release contains "forward-looking" statements,
including, among others, statements regarding ARQ-151’s potential
as a “Best-in-Class” PDE4 inhibitor, ARQ-151’s potential as a
treatment for atopic dermatitis and ARQ-151’s potential as a
treatment for plaque psoriasis. These statements involve
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 and you should not place undue reliance on our
forward-looking statements. Risks and uncertainties that may cause
our actual results to differ include risks inherent in the clinical
development process and regulatory approval process, the timing of
regulatory filings, and our ability to defend our intellectual
property. For a further description of the risks and uncertainties
applicable to our business, see the "Risk Factors" section of our
Form 10-Q filed with U.S. Securities and Exchange Commission (SEC)
on August 11, 2020, as well as any subsequent filings with the SEC.
We undertake no obligation to revise or update information herein
to reflect events or circumstances in the future, even if new
information becomes available.
Investors and Media:Heather Rowe ArmstrongVice
President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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