Arcutis Enrolls Last Patient in Phase 2b Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatme...
July 20 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 the
completion of enrollment of the Phase 2b clinical trial evaluating
ARQ-154 (topical roflumilast foam) as a potential treatment for
scalp psoriasis. 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 now anticipates
topline data from this trial in the fourth quarter of 2020.
“An estimated 8.6 million Americans are
afflicted with chronic psoriasis, and nearly half of those people
have scalp involvement, an area where topical treatment of scalp
plaques is complicated by the difficulty of delivering topical
drugs under the hair and to the surface of the skin,” said Frank
Watanabe, Arcutis’ President and Chief Executive Officer. “We
developed roflumilast foam as a convenient, once daily, easy-to-use
foam that is safe for chronic use and appropriate for application
in hair-bearing areas, such as the scalp, where a cream, lotion, or
ointment is not suitable. We believe roflumilast foam may provide a
new treatment option for physicians and patients, with the
potential to show significant symptomatic improvement similar to
high-potency steroids, while at the same time maintaining a low
risk of toxicity or side effects.”
Roflumilast foam is a topical foam formulation
of a highly potent and selective PDE4 inhibitor (roflumilast).
Roflumilast has been approved by the U.S. Food and Drug
Administration (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 scalp psoriasis treatment.
Roflumilast foam is nearly identical to ARQ-151 (topical
roflumilast cream), Arcutis’ topical cream PDE4 inhibitor that has
demonstrated statistically significant improvements of psoriasis
symptoms and a favorable tolerability profile in two separate Phase
2 studies. Psoriasis plaques on the scalp are identical to
plaques elsewhere on the body, so the roflumilast cream psoriasis
results should be highly predictive.
The Phase 2b trial in scalp psoriasis is an
8-week, multi-center, multi-national, double blind,
vehicle-controlled, study of the safety and efficacy of topical
roflumilast foam 0.3% administered once-daily in approximately 300
adult and adolescent patients with plaque psoriasis that includes
plaques on the scalp. The primary endpoint of the trial is
achievement of an Investigator Global Assessment score of 'clear'
or 'almost clear' plus a 2-grade improvement from baseline on the
scalp (S-IGA) at week 8. Multiple secondary endpoints will also be
evaluated.
About Scalp PsoriasisScalp
psoriasis is a manifestation of plaque psoriasis characterized by
raised, red areas of skin (“plaques”) covered with a silver or
white scale that occurs in the hair-bearing area of the scalp and
sometimes extending to the forehead, back of the neck, or behind or
inside the ears. Patients with scalp psoriasis commonly have
plaques on other areas of the body as well. Nearly half of
the estimated 8.6 million Americans with psoriasis have involvement
of the scalp. Scalp psoriasis plaques are identical to
psoriatic plaques on other areas of the body, however topical
treatment of scalp plaques is complicated by the difficulty of
delivering topical drugs under the hair and onto the skin. As with
psoriatic plaques on other parts of the body, psoriasis on the
scalp is often itchy and is sometimes painful. Scalp psoriasis can
also be associated with hair loss, likely due to damage to the hair
from excessive scratching, rubbing, or combing of the affected
area.
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
https://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
roflumilast foam’s potential as a scalp psoriasis treatment;
expectations with regard to the timing of clinical data anticipated
in the fourth quarter of 2020; and whether roflumilast cream’s
Phase 2 results may be predictive of roflumilast foam’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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