Arcutis Biotherapeutics to Accelerate ARQ-151 (Topical Roflumilast Cream) into Phase 3 Trials for the Treatment of Atopic Der...
September 08 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
plans to advance its program to develop ARQ-151 (topical
roflumilast cream) for the treatment of atopic dermatitis into
Phase 3 clinical trials following its End-of-Phase 2 meeting with
the U.S. Food and Drug Administration (FDA), without conducting the
previously planned Phase 2b atopic dermatitis trial. The Company
now anticipates initiating pivotal Phase 3 clinical trials in late
2020 or early 2021. ARQ-151 is a once-daily topical cream
formulation of roflumilast, a highly potent and selective
phosphodiesterase type 4 inhibitor (PDE4), which the Company is
developing for atopic dermatitis and psoriasis.
“Following our interactions with the FDA, we are delighted to be
able to accelerate the development of topical roflumilast cream
into Phase 3 trials for the treatment of atopic dermatitis, a
disease that affects almost 20 million people in the U.S., of which
approximately 60% are children,” said Patrick Burnett, M.D., Ph.D.,
FAAD, Arcutis’ Chief Medical Officer. “Results from previous
clinical trials have shown that our simple, easy-to-use, once-a-day
topical roflumilast cream provided efficacy results similar to
those seen with topical JAK inhibitors or mid-potency steroids
while also being well tolerated, which is critical in children.
By delivering efficacy that enables meaningful symptomatic
improvement and a favorable safety and tolerability profile that
supports chronic use for patients with atopic dermatitis, topical
roflumilast has the potential to overcome the significant
shortcomings of existing therapies, which could mitigate the need
for dermatologists and patients to make trade-offs in
efficacy, safety and tolerability.”
Roflumilast cream is a once-daily topical
cream formulation of a highly potent
and selective PDE4 inhibitor (roflumilast) that is
under development for atopic dermatitis and psoriasis. Oral
roflumilast has been approved by the
U.S. Food and Drug Administration
(FDA) for 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. Roflumilast
cream is already undergoing Phase 3 clinical trials for the
treatment of plaque psoriasis, with topline data expected in the
first half of 2021.
About Atopic DermatitisAtopic
dermatitis (AD) is the most common type of eczema, occurring in
approximately six percent of the U.S. population. AD is
characterized by a defect in the skin barrier, which allows
allergens and other irritants to enter the skin, leading to an
immune reaction and inflammation. This reaction produces a
red, itchy rash, most frequently occurring on the face, arms and
legs, and the rash can cover significant areas of the body, in some
cases half of the body or more. Disease onset is most common
by 5 years of age, and the Company estimates that approximately 60%
of patients suffering from AD are pediatric patients. The
rash causes significant pruritus (itching), which can lead to skin
damage caused by scratching or rubbing. Given that most of
the patients are pediatric, the safety and tolerability of AD
therapies are paramount.
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 the potential of roflumilast
cream to address the unmet needs in the topical treatment of atopic
dermatitis; the potential safety and efficacy of roflumilast cream;
and the initiation of pivotal Phase 3 clinical trials
in late 2020 or in early 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 August 11,
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
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