Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage company focused on developing meaningful
innovations in immuno-dermatology, today announced the publication
of positive patient-reported outcome itch data from its Phase 2b
study evaluating once-daily roflumilast cream (0.3% and 0.15%) in
adults with chronic plaque psoriasis. The study, which was
published online in the American Journal of Clinical Dermatology
shows that those treated with roflumilast cream 0.3% experienced
significantly greater improvements in WI-NRS as well as severity
and bother of itch (as measured by PSD) by the earliest timepoint
measured, Week 2, and itch-related sleep loss from Weeks 6 through
12, than those treated with vehicle. Roflumilast is a selective,
highly potent phosphodiesterase-4 inhibitor (PDE4), with greater
affinity for PDE4 and approximately 25- to >300-fold more
potency than other FDA-approved PDE4 inhibitors.
“As a clinician and researcher, I see first-hand how itch can
negatively affect people with chronic plaque psoriasis, in
particular on the quality and quantity of their sleep,” said Linda
Stein Gold, MD, Director of Dermatology Clinical Research and
Division Head of Dermatology at Henry Ford Health System and lead
author of the paper. “These data show that roflumilast cream is an
important non-steroidal treatment option that is able to address
this burdensome symptom of plaque psoriasis, and provide those
struggling with itch much-needed, and rapid relief, as early as two
weeks.”
In the parallel-group, double-blind, vehicle-controlled phase 2b
clinical trial, 331 subjects ranging from ages 18 to 89 years were
randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or
vehicle in a 1:1:1 ratio. Roflumilast cream or vehicle was applied
once daily to all psoriasis lesions for 12 weeks.
Improvement in WI-NRS was greater in individuals treated with
roflumilast cream in both arms compared to vehicle beginning at
Week 2 (p ≤ 0.002), the first timepoint measured. Among a subgroup
of participants with a baseline WI-NRS >6, significantly more of
those treated with roflumilast 0.3% achieved an improvement of ≥4
compared to vehicle by Week 2 (p ≤ 0.034).
Those treated with roflumilast cream in both arms reported
greater improvements in severity of itch and bother of itch, as
measured by PSD, compared to vehicle at Weeks 2 to 12 (p < 0.012
and p < 0.010, respectively). Additionally, both
roflumilast-treated groups experienced similar improvements in
itch-related sleep loss as measured by itch-related sleep loss NRS,
which was greater than the vehicle-treated group beginning at Week
6 (p ≤ 0.022). Improvement on the Dermatology Life Quality Index
(DLQI) Score was observed at Week 6 for those treated with
roflumilast cream 0.3% compared to those treated with vehicle (p =
0.045) and for both roflumilast-treated groups at Week 12.
“These findings not only help us to better understand the role
of roflumilast cream in addressing the often-challenging symptom of
itch in individuals with chronic plaque psoriasis, but also shed
light on how people living with the disease may experience itch,
regardless of their disease severity, and its impact on their
lives,” said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer
at Arcutis. “We are pleased to share these data with the medical
dermatology community through publication in this excellent
journal. We believe the ability to rapidly reduce itch, coupled
with the safety and tolerability of now approved ZORYVE roflumilast
cream is a key differentiator.”
In July 2022, ZORYVE® (roflumilast) cream 0.3% was approved for
the topical use in adults and adolescents with mild to severe
plaque psoriasis, including intertriginous psoriasis.
To learn more about the data, view the full text of “Effect of
Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in
Adults with Chronic Plaque Psoriasis: Patient-Reported Itch
Outcomes of a Phase 2b Trial” here:
https://link.springer.com/article/10.1007/s40257-022-00739-3.
About ZORYVE (roflumilast) Cream 0.3%ZORYVE
(roflumilast) cream 0.3% is a next generation topical inhibitor of
phosphodiesterase-4 (PDE4) and the first topical PDE4 inhibitor to
be approved by the FDA for adults and adolescents with plaque
psoriasis, including intertriginous psoriasis.
INDICATIONZORYVE (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 a 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 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 psoriasis,
atopic dermatitis, and seborrheic dermatitis. 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 for ZORYVE to
simplify disease management for care of plaque psoriasis; the
potential of real-world use results of roflumilast cream, as well
as the commercial launch of ZORYVE in plaque psoriasis. 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 22, 2022, as amended, 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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