Arcutis Announces First Patient Enrolled in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treat...
July 12 2021 - 8:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing meaningful
innovations to address the urgent needs of patients living with
immune-mediated dermatological diseases and conditions, or
immuno-dermatology, today announced enrollment of the first patient
in its single pivotal Phase 3 clinical trial evaluating topical
roflumilast foam (ARQ-154) as a potential treatment for seborrheic
dermatitis. Roflumilast foam is a once-daily topical foam
formulation of roflumilast, a highly potent and selective
phosphodiesterase type 4 (PDE4) inhibitor, which the Company is
developing for seborrheic dermatitis and scalp psoriasis.
“The symptoms of seborrheic dermatitis can have a significant,
negative influence on quality of life and can cause psychological
distress for millions of affected Americans. Despite that, no novel
treatments have been developed for this chronic skin condition in
decades, and current topical treatments frequently provide
inadequate efficacy or pose safety concerns that limit their use,”
said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of
Arcutis. “In our Phase 2 trial, roflumilast foam was demonstrated
to be an effective, safe, and well-tolerated treatment for
seborrheic dermatitis. We are now pleased to initiate this single
Phase 3 pivotal trial, as we believe roflumilast foam, if approved,
has the potential to become a much-needed new standard of care for
people with seborrheic dermatitis. Unlike most treatments,
roflumilast foam is suitable for all body areas, including
hair-bearing areas and the face, and does not pose the safety
concerns typically seen with topical steroids.”
The STudy of Roflumilast foam Applied Topically for the
redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel
group, double blind, vehicle-controlled study of the safety and
efficacy of roflumilast 0.3% foam administered once-daily in
approximately 450 subjects ages nine and older with moderate to
severe seborrheic dermatitis. The primary endpoint of the study is
the proportion of subjects achieving Investigator Global Assessment
(IGA) success, defined as an IGA score of “clear” or “almost clear”
plus a 2-point improvement at eight weeks. The Company announced in
January 2021 that it had conducted a successful End-of-Phase 2
meeting with the U.S. Food and Drug Administration (FDA) and
planned to initiate a single pivotal Phase 3 trial in seborrheic
dermatitis.
About Seborrheic DermatitisSeborrheic
dermatitis affects more than 10 million people in the U.S., and is
a common, chronic, or recurrent inflammatory skin disease that
causes red patches covered with large, greasy, flaking yellow-gray
scales, and persistent itch. Seborrheic dermatitis occurs most
often on the scalp, face (especially on the nose, eyebrows, ears,
and eyelids), upper chest, and back.About Topical
Roflumilast Foam Roflumilast foam is a once-daily, topical
formulation of a highly potent and selective PDE4 inhibitor
(roflumilast). The foam formulation was designed to treat
hair-bearing areas of the body, such as the scalp, although it is
usable in all areas of the body, including the face. Roflumilast
has been approved by the U.S. Food and Drug Administration (FDA)
for oral treatment to reduce the risk of exacerbations of chronic
obstructive pulmonary disease (COPD) since 2011. Roflumilast has
shown greater potency (25- to 300-fold) than the two other
FDA-approved PDE4 inhibitors for dermatology. PDE4 is an
intracellular enzyme that increases the production of
pro-inflammatory mediators and decreases production of
anti-inflammatory mediators; it has been implicated in a wide range
of inflammatory diseases including psoriasis, atopic dermatitis,
and COPD. PDE4 is an established target in dermatology, and other
PDE4 inhibitors have been approved by the FDA for the topical
treatment of atopic dermatitis and the systemic treatment of plaque
psoriasis.About ArcutisArcutis Biotherapeutics,
Inc. (Nasdaq: ARQT) is a medical dermatology company that champions
meaningful innovation to address the urgent needs of patients
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 seven clinical programs for a range
of inflammatory dermatological conditions, with our first NDA
submission anticipated by the end of 2021 and three more Phase 3
clinical data readouts anticipated over the next 18 months. The
company’s lead product candidate, topical roflumilast, has the
potential to advance the standard of care for plaque psoriasis,
atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For
more information, visit www.arcutis.com or follow Arcutis
on LinkedIn and Twitter.Forward-Looking
StatementsThis press release contains "forward-looking"
statements, including, among others, statements regarding the
potential for roflumilast to revolutionize the standard of care in
seborrheic dermatitis and other inflammatory dermatological
conditions. 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-K filed with U.S. Securities and
Exchange Commission (SEC) on February 16, 2021, 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.
Investor and Media Contact:ir@arcutis.com
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