Arcutis Completes Enrollment in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluating ARQ-151 (Topical Roflumilast...
September 16 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 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.
“Patients with plaque psoriasis, a common
immune-mediated skin disease, are desperate for new topical options
that, unlike existing treatments, don’t require them to make
trade-offs between efficacy, safety, and tolerability,” said
Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer.
“We are delighted to complete enrollment in 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. In two separate prior Phase 2 studies,
roflumilast cream demonstrated statistically significant
symptomatic improvements and a safety and tolerability profile that
supports chronic use and the ability to use in all body areas. We
are updating our guidance and now plan to announce topline data
from these pivotal Phase 3 trials in the first quarter of 2021 and,
if positive, anticipate submission of our NDA to the FDA by the end
of 2021.”
Arcutis recently announced positive preliminary
results from the first cohort in its ongoing Phase 2 long-term
safety study in psoriasis, supporting its belief that roflumilast
cream can be used chronically. 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
StatementsThis 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 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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