Arcutis Announces Last Patient Completes Final Study Visit in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluatin...
December 07 2020 - 8:00AM
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
that the last participant has completed the 8-week treatment period
in DERMIS-1 and DERMIS-2, the Company’s pivotal Phase 3 clinical
trials evaluating ARQ-151 (topical roflumilast cream) as a
potential topical treatment for plaque psoriasis.
“Plaque psoriasis affects approximately 8.6
million patients in the U.S., many of whom are desperate for new
topical options that don’t require them to make trade-offs,” said
Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer.
“We are delighted to complete DERMIS-1 and DERMIS-2, our pivotal
phase 3 clinical trials evaluating roflumilast cream as a potential
once daily topical treatment for plaque psoriasis. If approved, we
believe roflumilast cream has the potential to eliminate the need
for dermatologists and patients to compromise between efficacy and
safety. We anticipate announcing topline data from these trials in
the first quarter of 2021 and, if positive, anticipate submission
of our NDA to the FDA by the end of 2021. We are immensely grateful
to the trial participants and the clinical investigators for their
time and commitment to this important research effort.”
Arcutis recently announced positive results from
its Phase 2 long-term safety study in plaque psoriasis, which
support chronic use of roflumilast cream. In addition, The New
England Journal of Medicine published results from the
double-blind, randomized Phase 2b study of roflumilast cream in
plaque psoriasis.
The “Trials of PDE4 inhibition
with Roflumilast for the
Management of plaque PsoriasIS”
One and Two (or DERMIS-1 and DERMIS-2) are identical Phase 3
randomized, parallel, double-blind, vehicle-controlled,
multi-national, multi-center studies in which roflumilast 0.3%
cream or vehicle cream are applied once daily for 8 weeks to
subjects age 2 years and above with mild, moderate or severe
chronic plaque psoriasis involving between 2% and 20% body surface
area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442
subjects. The primary endpoint of the studies is Investigator
Global Assessment (IGA) Success, defined as an IGA score of clear
or almost clear and at least a 2-grade improvement from baseline at
week 8 on the IGA score. Multiple secondary endpoints will also be
evaluated, including Intertriginous IGA (I-IGA) Success, and
improvements in Psoriasis Area Severity Index (PASI), 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). The Company anticipates topline data from the
Phase 3 studies in the first quarter of 2021 and, if positive,
anticipates submission of its NDA to the FDA by the end of
2021.
About Topical Roflumilast
Cream
Roflumilast 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 Psoriasis
Psoriasis is a common, non-contagious,
immune-mediated skin disease that affects approximately 8.6 million
patients in the United States. About 90% of patients develop plaque
psoriasis, which is characterized by raised, red areas of skin
covered with a silver or white layer of scale. Psoriatic plaques
can appear on any area of the body, but most often appear on the
scalp, knees, elbows, trunk, and limbs, and are often itchy and
sometimes painful. Plaques in certain anatomical areas present
particular treatment challenges, including the face, elbows and
knees, scalp, and intertriginous regions such as the groin, axillae
and inframammary areas.
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 Statements
This press release contains "forward-looking"
statements, including, among others, statements regarding
roflumilast cream’s potential as a psoriasis treatment; and
expectations with regard to the timing of clinical data anticipated
in the first quarter of 2021 and NDA submission by the end of 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.
Contact:Heather Rowe
ArmstrongVice President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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