Arcutis Enrolls Last Patient in Phase 2 Proof of Concept Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Po...
June 22 2020 - 9:00AM
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 it
had completed enrollment of its Phase 2 proof of concept clinical
trial evaluating roflumilast foam as a potential treatment for
seborrheic dermatitis. Roflumilast foam is a once-daily
topical foam formulation of a highly potent and selective
phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that the
Company is developing particularly to treat inflammatory dermatoses
in hair-bearing areas of the body such as the scalp. The Company
anticipates topline data from this trial early in the fourth
quarter of 2020. In addition, the Company has begun enrollment in a
long-term safety study of roflumilast foam in patients with
seborrheic dermatitis.
“Seborrheic dermatitis is a common chronic skin
disease that primarily occurs on the scalp, face and chest, and is
one of the most neglected diseases in dermatology. There are more
than six million sufferers in the U.S., many not knowing what it is
and thinking it’s just dry skin, and more than 1.5 million who will
receive a prescription topical treatment for this condition each
year,” said Mark Jackson, MD, Clinical Professor of Medicine
(Dermatology) at the University of Louisville. “I believe a
significant need exists for novel non-steroidal therapies to treat
this disease, particularly for patients who don’t adequately
respond to existing treatments. The greatest reward as a physician
comes from seeing patients with distressing chronic skin conditions
improve with effective treatments. There is a significant need to
find better treatment options for patients with seborrheic
dermatitis and I look forward to seeing the results from this
trial.”
“We are delighted with the strong support from
investigators and the speed with which they enrolled this study,
both of which underscore the demand for safe and effective new
treatments for seborrheic dermatitis,” said Frank Watanabe,
Arcutis’ President and Chief Executive Officer. “Roflumilast foam
was developed as an easy-to-use once daily foam specifically to
treat hair-bearing areas of the body like the scalp, where
seborrheic dermatitis occurs, and where a cream, lotion, or
ointment is not suitable. A non-steroidal treatment is also
preferable for treatment of the mid-face area, especially
around the eyes, due to the risks associated
with ocular steroid exposure. We believe roflumilast foam
has the potential to be the first treatment with a new mechanism of
action for seborrheic dermatitis in decades. We expect to announce
topline data from this trial by early in the fourth quarter of this
year.”
Roflumilast foam is a topical foam formulation
of a highly potent and selective PDE4 inhibitor (roflumilast).
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.
Roflumilast foam is nearly identical to ARQ-151 (topical
roflumilast cream), Arcutis’ investigational topical cream PDE4
inhibitor that has demonstrated symptomatic improvement and a
favorable tolerability profile in the Company’s clinical trials in
plaque psoriasis, as well as encouraging results in atopic
dermatitis.
The Phase 2 proof of concept trial in moderate
to severe seborrheic dermatitis is an 8-week, multi-center,
multi-national, double blind, vehicle-controlled study of the
safety and efficacy of roflumilast foam 0.3% administered
once-daily. The primary endpoint of the trial is achievement of an
Investigator Global Assessment Scale (IGA) score of 'clear' or
'almost clear' plus a 2-grade improvement from baseline at week 8.
This global assessment scale has five severity grades reported from
0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate
(3), Severe (4).
The Phase 2 long-term safety study is a
multicenter, open-label study of roflumilast foam 0.3% applied once
daily in patients with moderate to severe seborrheic dermatitis
involving up to 20% total Body Surface Area (BSA). Cohort 1 will
include patients who rolled over from the Phase 2 proof-of-concept
trial while Cohort 2 will include patients naïve to treatment with
topical roflumilast foam. Periodic clinic visits will include
assessments for clinical safety, application site reactions, and
disease improvement, or progression.
About Seborrheic
DermatitisSeborrheic dermatitis is a common, chronic or
recurrent skin condition 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 and around the nose, eyebrows, and eyelids), ears,
upper chest and back.
About Arcutis - Bioscience, applied to the
skin.
Arcutis 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. Arcutis exploits recent
innovations in inflammation and immunology to develop potential
best-in-class therapies against validated biological targets,
leveraging our deep development, formulation and commercialization
expertise to bring to market novel dermatology treatments, while
maximizing our probability of technical success and financial
resources. Arcutis is currently developing four novel
compounds, including ARQ-151 (topical roflumilast cream); ARQ-154
(topical roflumilast foam); ARQ-252, and ARQ-255 for multiple
indications, including psoriasis, atopic dermatitis, seborrheic
dermatitis, and eczema, vitiligo, and alopecia areata. For more
information, please visit www.arcutis.com or follow the Company on
LinkedIn.
Forward Looking StatementsThis
press release contains "forward-looking" statements, including,
among others, statements regarding ARQ-154’s potential as a
seborrheic dermatitis treatment; expectations with regard to the
timing of topline data anticipated by early in the fourth quarter
of 2020; and whether ARQ-151 Phase 2 results may be predictive of
ARQ-154’s potential clinical outcomes. 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 May 12, 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.
Contact:Heather Rowe Armstrong Vice President,
Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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