Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis
October 04 2021 - 8:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq:
ARQT), a late-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology to address the urgent
needs of patients living with immune-mediated dermatological
diseases and conditions, today announced it has submitted a new
drug application (NDA) to the U.S. Food and Drug Administration
(FDA) for roflumilast cream for the treatment of mild-to-severe
plaque psoriasis.
Roflumilast cream (ARQ-151) is a once-daily topical formulation
of roflumilast, a highly potent and selective inhibitor of
phosphodiesterase type 4 (PDE4), an enzyme that drives overactive
immune responses. In clinical trials, roflumilast cream
demonstrated robust efficacy coupled with favorable safety and
tolerability that, if approved, would enable chronic use across the
body, without many of the local tolerability issues associated with
alternative treatments.
“Today is a critical milestone for Arcutis in our efforts to
bring innovative treatments to dermatologists and their patients,
and is a reflection of our deep dermatology expertise,” said Frank
Watanabe, President and CEO of Arcutis. “Individuals with plaque
psoriasis currently do not have topical treatment options that
offer a combination of good tolerability and the ability to be used
for long periods of time, and that can be used on all parts of the
body. If approved, roflumilast cream will be the first and only
topical PDE4 inhibitor approved for psoriasis and an important
non-steroidal treatment option for the millions of individuals
struggling with plaque psoriasis. I want to thank the Arcutis team,
as well as the clinical investigators, patients, and partners, for
helping us reach this important milestone.”
Psoriasis is a common, non-contagious, immune-mediated skin
disease that affects more than 3% of the U.S. population. The
majority of patients develop “plaques,” or raised, red areas of
skin covered with a silver or white layer of dead skin cells.
Psoriatic plaques are often itchy and sometimes painful, and can
appear on any area of the body. Plaques in certain anatomical areas
present particular treatment challenges, including the face, elbows
and knees, scalp, and areas where two skin areas may touch or rub
together.
Topical treatments are the mainstay of therapy for the vast
majority of psoriasis patients, particularly those with
mild-to-moderate disease, as well as many moderate-to-severe
patients who use topicals in combination with other treatments.
However, existing topical treatments often force physicians and
patients to make difficult trade-offs between tolerability and
long-term use, requiring the use of multiple products or
complicated treatment schedules. Roflumilast cream has been
designed to address the challenges posed to dermatologists and
patients by existing topical therapies and aims to simplify the
overall management of plaque psoriasis.
Arcutis’ submission is supported by positive data from Arcutis’
pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 (Trials of
PDE4 inhibition
with Roflumilast for
the Management of plaque
PsoriasIS” One and Two) were identical Phase 3
randomized, parallel, double-blind, vehicle-controlled,
multi-national, multi-center studies to evaluate the safety and
efficacy of roflumilast cream 0.3%. Roflumilast met its
primary endpoint and had an ‘IGA Success’ rate of 42.4% compared to
a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a
vehicle rate of 6.9% (P<0.0001), in DERMIS 1 and 2 respectively.
Roflumilast cream 0.3% also demonstrated statistically significant
improvements over vehicle on key secondary endpoints, including on
Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity
Index-75 (PASI-75), reductions in itch as measured by the Worst
Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of
symptoms as measured by the Psoriasis Symptoms Diary (PSD). In
trials, roflumilast cream was generally well-tolerated with a
favorable safety and tolerability profile. About
Roflumilast CreamRoflumilast Cream is a topical cream
formulation of a highly potent and selective PDE4 inhibitor,
roflumilast. 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. PDE4 is an
intracellular enzyme that increases the production of
pro-inflammatory mediators and decreases production of
anti-inflammatory mediators and has been implicated in a wide range
of inflammatory diseases including psoriasis, eczema, 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 or 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 multiple clinical programs for a range of
inflammatory dermatological conditions, with one NDA submission now
under review with the FDA and three Phase 3 clinical data readouts
anticipated by the end of 2022. The company’s lead program, 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 be
approved for the treatment of adults and adolescents with plaque
psoriasis, the potential to use roflumilast cream over a long
period of time, or chronically, and the potential for roflumilast
to revolutionize the standard of care in plaque psoriasis 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.
Contacts:MediaAmanda Sheldon,
Head of Corporate Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@arcutis.com
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