Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial
January 29 2024 - 8:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced that
the Journal of American Academy of Dermatology (JAAD) published
positive results from the pivotal Phase 3 STRATUM trial evaluating
ZORYVE (roflumilast) foam, 0.3% as a once-daily steroid-free
treatment for seborrheic dermatitis. The article was published
online, and found that treatment with ZORYVE foam was superior to
vehicle, with 80% of individuals achieving the primary efficacy
endpoint of Investigator Global Assessment (IGA) Success and 51% of
individuals reaching complete clearance at Week 8. ZORYVE foam was
approved by the U.S. Food and Drug Administration (FDA) for
treatment of seborrheic dermatitis in adult and pediatric patients
9 years of age and older in December 2023 and is the first
drug approved for seborrheic dermatitis with a new mechanism of
action in over two decades.
“Despite being very common, seborrheic dermatitis has
traditionally been a disease with limited treatment options. It
also can have a significant impact on quality of life,”
stated Dr. Andrew Blauvelt, MD, MBA, lead study author and
investigator at the Oregon Medical Research Center. “The
publication of the Phase 3 STRATUM study results in
the Journal of American Academy of Dermatology further
validates the significance of roflumilast foam as a
new treatment option for seb derm, one that provides treatment
success in eight of ten patients, along with significant and
rapid improvements in key signs and symptoms of disease, as early
as two weeks. These results highlight the effectiveness and
safety of roflumilast foam, a steroid-free treatment and the first
novel mechanism of action approved for seb derm in two decades. It
should end suffering from this long-neglected condition.”
“Seborrheic dermatitis is challenging to manage, and often
people with the disease require several different treatments for
different areas of their body. Our focus has been to simplify the
treatment of seborrheic dermatitis with an effective once-daily
steroid-free foam that is suitable for use anywhere on the body for
any duration and on all hair and skin types,” said Patrick Burnett,
MD, PhD, FAAD, chief medical officer of Arcutis. “We are pleased
that this manuscript is now available to provide dermatology
clinicians with a greater understanding of the clinical data
supporting ZORYVE foam as a newly approved treatment option for
their patients.”
The STudy of Roflumilast
foam Applied Topically for the redUction of seborrheic
derMatitis (STRATUM) was a parallel group, double-blind,
vehicle-controlled study evaluating the safety and efficacy of
ZORYVE (roflumilast) foam, 0.3% in seborrheic dermatitis. The
trial enrolled 457 adults and adolescents with moderate to severe
seborrheic dermatitis affecting up to 20% body surface area (BSA),
including the scalp, face, trunk, and/or intertriginous areas.
- The STRATUM study
met its primary endpoint, with 80% of roflumilast foam treated
individuals reaching IGA Success rate at Week 8 (79.5% ZORYVE foam
vs. 58.0% vehicle; p<0.0001). IGA Success was defined as an IGA
score of clear or almost clear plus a ≥2 grade improvement from
baseline.
- Improvement was
seen early, with roflumilast foam demonstrating a statistically
significant improvement compared to vehicle on IGA Success at Week
2, the first timepoint assessed in STRATUM.
- In addition, 50.6%
of individuals in the roflumilast foam treated arm reached complete
clearance (IGA=0) at Week 8.
- Roflumilast foam
also demonstrated statistically significant improvement over
vehicle on all secondary endpoints, including itch, scaling, and
erythema (redness).
- More than 60% of
individuals achieved a ≥4-point reduction in itch at Week 8 as
measured by Worst Itch-Numerical Rating Score (62.8% roflumilast
foam vs. 40.6% vehicle; p=0.0001), and significant improvements in
itch were also reported at Week 2 and Week 4.
- Individuals treated
with ZORYVE foam reported a 28% improvement in itch from baseline
in 48 hours (compared to 13% on vehicle nominal p=0.0024).
- More than 50% of
individuals treated with ZORYVE foam achieved an erythema (redness)
score of 0, and more than 50% achieved a scaling score of 0, at
Week 8.
- Treatment with
ZORYVE foam demonstrated a significantly larger improvement in
patient reported outcomes as early as Week 2 as measured through
Dermatology Life Quality Index (DLQI), with improvements maintained
through Week 8.
ZORYVE foam was well-tolerated with a favorable safety and
tolerability profile. The incidence of Treatment Emergent Adverse
Events (TEAEs) was low and similar between active treatment and
vehicle, with most TEAEs assessed as mild to moderate severity.
There were no treatment-related Serious Adverse Events (SAEs). The
most common adverse reactions (≥1%) reported, per the prescribing
information, include nasopharyngitis (1.5%), nausea (1.3%), and
headache (1.1%).
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 U.S. 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.
INDICATIONZORYVE 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%) include nasopharyngitis
(1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information.
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 of ZORYVE foam to
simplify disease management for care of seborrheic dermatitis; the
potential of real-world use results of ZORYVE foam, as well as the
commercial launch of ZORYVE foam in seborrheic dermatitis. 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
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