Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing and commercializing
treatments for unmet needs in immune-mediated dermatological
diseases and conditions, or immuno-dermatology, today announced
that it will advance its program to develop topical roflumilast
foam (ARQ-154) as a treatment for seborrheic dermatitis into Phase
3 following an End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA). The Phase 3 program will consist of a single
pivotal trial, which the Company anticipates initiating in the
second or third quarter of 2021. Roflumilast foam is a once-daily
topical foam formulation of roflumilast, a highly potent and
selective phosphodiesterase type 4 (PDE4) inhibitor.
“Following our interactions with the FDA, we are delighted to
advance topical roflumilast foam into Phase 3 development for the
treatment of seborrheic dermatitis, a disease that affects more
than 10 million people in the U.S.,” said Patrick Burnett, M.D.,
Ph.D., FAAD, Arcutis’ Chief Medical Officer. “Results from our
Phase 2 clinical trials with once-a-day topical roflumilast foam
demonstrated that it provides statistically significant
improvements in signs and symptoms of both seborrheic dermatitis
and scalp psoriasis compared to a matching vehicle foam, while also
being well tolerated. Unlike creams and ointments, roflumilast foam
is suitable for use in hair-bearing areas; unlike steroids, it is
expected to be suitable for long-term use, including on the face;
and unlike shampoos, it is an elegant, quick drying, leave-in foam
that doesn’t need to be rinsed out. If successful in the Phase 3
clinical trial and approved for commercialization, roflumilast foam
has the potential to become the standard of care in seborrheic
dermatitis.”
“Patients are desperate to find new treatment options for
seborrheic dermatitis, a common, chronic skin disease affecting the
face and scalp that can profoundly affect patients’ appearance and
quality of life,” said Matthew Zirwas, M.D., Founder of Bexley
Dermatology Research Clinic and an investigator in the trial.
“Dermatologists and patients face a real challenge, with current
treatment options that are either safe or effective, but rarely
both. Based on clinical results to date, topical roflumilast has
shown to be safe and effective, rapidly improving both the
appearance and the itch, dramatically improving patients’ quality
of life. Notably, it comes in a cosmetically-elegant foam that can
be used chronically in multiple locations without the burning and
stinging associated with other treatment options. If approved,
topical roflumilast will be a revolutionary advancement in the
treatment of seborrheic dermatitis.”
Roflumilast foam is a once-daily topical foam
formulation of a highly potent and selective PDE4 inhibitor that
Arcutis is developing particularly to treat inflammatory dermatoses
in hair-bearing areas of the body such as the scalp, although it is
usable in all areas of the body.
Roflumilast has been approved by the FDA for
systemic 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.
Arcutis believes roflumilast foam has
significant potential as a treatment for seborrheic dermatitis. In
a recently completed Phase 2 study of roflumilast foam in
seborrheic dermatitis, roflumilast foam demonstrated statistically
significant improvement over the vehicle foam on the trial’s
primary endpoint, Investigator Global Assessment (IGA) success, and
multiple secondary endpoints including the reduction of itch.
Once-daily roflumilast foam also demonstrated a favorable safety
and tolerability profile. Additionally, other than a very small
change in the formulation, roflumilast foam is identical to
roflumilast cream (ARQ-151), Arcutis’ investigational topical cream
PDE4 inhibitor, which has demonstrated symptomatic improvement and
a favorable tolerability profile in clinical trials in plaque
psoriasis, including chronic treatment of psoriasis, as well as
encouraging results in atopic dermatitis.
Arcutis is currently conducting a Phase 2
long-term safety study in seborrheic dermatitis. This is a
multicenter, open-label study of roflumilast foam 0.3% applied once
daily in adolescent and adult patients with seborrheic dermatitis
and includes patients who were treated previously in the Phase 2
trial, as well as patients naïve to treatment with topical
roflumilast foam. Periodic clinic visits include assessments for
clinical safety, application site reactions, and disease
improvement, or progression.
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 Arcutis - Bioscience, applied to the
skin.Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage
biopharmaceutical company focused on developing and commercializing
treatments for unmet needs in immune-mediated dermatological
diseases and conditions, or immuno-dermatology. The company is
leveraging recent advances in immunology and inflammation to
develop differentiated therapies against biologically validated
targets to solve persistent treatment challenges in serious
diseases of the skin. Arcutis’ robust pipeline includes four novel
drug candidates currently in development for a range of
inflammatory dermatological conditions. The company’s lead product
candidate, topical roflumilast, has the potential to revitalize the
standard of care for plaque psoriasis, atopic dermatitis, scalp
psoriasis, and seborrheic dermatitis. For more information, visit
www.arcutis.com or follow the company on LinkedIn and Twitter.
Forward Looking StatementsThis
press release contains "forward-looking" statements, including,
among others, statements regarding the potential of roflumilast
foam to address the unmet needs in the topical treatment of
seborrheic dermatitis; the potential safety and efficacy of
roflumilast foam; and the initiation of a pivotal Phase 3 clinical
trial in 2021. 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-Q filed with U.S. Securities and
Exchange Commission (SEC) on November 5, 2020, 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.
Investors and Media:Heather Rowe ArmstrongVice
President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
Arcutis Biotherapeutics (NASDAQ:ARQT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Arcutis Biotherapeutics (NASDAQ:ARQT)
Historical Stock Chart
From Apr 2023 to Apr 2024