Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis
14 January 2023 - 08:00PM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage company focused on developing meaningful
innovations in immuno-dermatology, today announced new safety and
efficacy durability data from its open label Phase 2 long-term
safety study evaluating once-daily roflumilast cream (0.3%) in
adults with chronic plaque psoriasis. Roflumilast cream 0.3%
(ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4
(PDE4) inhibitor approved by the US Food and Drug Administration in
July 2022.
The study, which was presented at the Winter Clinical
dermatology meeting, showed that during the trial, 57.1% (n=185) of
roflumilast cream-treated patients achieved an Investigator Global
Assessment (IGA) score of clear or almost clear (IGA 0/1) at any
time in study, and these participants had a median duration of IGA
of clear or almost clear of more than 10 months (40.1 weeks).
Additionally, the percentages of participants achieving IGA success
(defined as clear/almost clear plus 2-grade improvement from
baseline) and an IGA of clear or almost clear were maintained over
the course of the 52 weeks, and were consistent with the DERMIS
trials. Roflumilast cream was safe and very well tolerated, with
the majority of adverse events (AEs) mild-to-moderate in
severity.
"We know roflumilast cream is a safe and effective treatment
option for those with plaque psoriasis, but what makes these data
so exciting is that it shows roflumilast cream continues to be
effective over a long period of time with no signs of
tachyphylaxis, which is an important consideration when choosing a
treatment option for a chronic skin condition,” said Mark Lebwohl,
MD, FAAD, principal investigator and Dean for Clinical Therapeutics
and Chairman Emeritus of the Kimberly and Eric J. Waldman
Department of Dermatology at the Icahn School of Medicine at Mount
Sinai; and a paid consultant and investigator for Arcutis.
“Importantly, the trial design allowed patients to use roflumilast
cream 0.3% similar to how it is expected to be used in the real
world, adjusting application for clearance of lesions across the
body while maintaining results.”
In the multicenter, open-label, single-arm, long-term Phase 2
safety trial, two cohorts of participants were enrolled (n=332).
Cohort-1 participants (n=230) were those who completed the Phase 2b
trial through Week 12 (roflumilast 0.3% treated, roflumilast 0.15%
treated, and vehicle treated), whereas Cohort-2 participants
(n=102) were newly enrolled (treatment-naïve at baseline).
Additional key findings following 52 weeks of treatment with
roflumilast cream 0.3% include:
- IGA success was achieved by 35.3% of participants previously
treated with roflumilast cream and 37.5% of roflumilast-naïve
participants. IGA success was defined as clear/almost clear plus
2-grade improvement from baseline
- 42% of participants previously treated with roflumilast cream
and 47.5% of roflumilast-naïve participants achieved an IGA score
of clear or almost clear (IGA 0/1) at Week 52
- 66.7% of participants in Cohort-21 achieved Intertriginous-IGA
(I-IGA) success, defined as clear or almost clear plus 2-grade
improvement from baseline
- No tachyphylaxis occurred, and efficacy was consistent over
time among participants who achieved an IGA of clear or almost
clear.
“These new findings are significant, as the data build upon
previous results from our clinical trial programs and our FDA
approval, demonstrating durable safety and long-term efficacy of
roflumilast cream for those with psoriasis, including people with
the condition in intertriginous areas,” said Patrick Burnett, MD,
PhD, FAAD, Chief Medical Officer at Arcutis. “This growing body of
evidence continues to reinforce that ZORYVE should be a preferred
treatment option for those with this condition - especially in
areas of the body that are traditionally difficult to treat.”
Safety data showed rates of discontinuations due to AEs were
low, and ≥97% of patients had no evidence of irritation per
investigator local tolerability assessment at each visit. The most
common AEs over the course of the trial (>2%) were upper
respiratory tract infection/viral URTI (6.6%), nasopharyngitis
(3.6%), urinary tract infection (3.3%), and sinusitis (2.4%).
——————————————————1Cohort 1 not shown because I-IGA added as
study amendment and numbers of patients evaluated are very small at
each timepoint.
About ZORYVE (roflumilast) Cream 0.3%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 for ZORYVE to
simplify disease management for care of plaque psoriasis; the
potential of real-world and long-term 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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