Arcutis Announces Inclusion of Children in On-going Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast (ARQ-151) ...
March 16 2020 - 8:37AM
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, at the request of the U.S. Food and Drug Administration
(FDA), Arcutis has submitted a protocol amendment to the FDA to
include children ages 2 to 11 years old in the Company’s on-going
DERMIS-1 and DERMIS-2 pivotal Phase 3 clinical trials evaluating
topical roflumilast cream as a potential topical treatment for
plaque psoriasis. The trials’ previous inclusion criteria included
patients ages 12 and above.
“After consultations with the FDA, we are
delighted that the Agency requested expanding the inclusion
criteria to include children as young as two years of age in our
pivotal Phase 3 clinical trials in patients with plaque psoriasis,”
said Howard Welgus, MD, Chief Medical Officer at Arcutis. “Many
treatment options approved for adults for this chronic skin
condition have not been studied in children, a population where
additional caution regarding safety and tolerability is paramount.
As no cure for psoriasis exists, patients and dermatologists need
new and better topical treatment options to manage this chronic
inflammatory condition. Based on its safety, tolerability and
efficacy profile in our completed clinical trials, we believe
topical roflumilast has the potential to be both the best-in-class
topical PDE4 inhibitor and the only topical PDE4 inhibitor approved
for plaque psoriasis, including in children."
Topical roflumilast cream (ARQ-151) contains the
highly potent and selective phosphodiesterase type 4 (PDE4)
inhibitor roflumilast, which was approved globally for the systemic
treatment of chronic obstructive pulmonary disease (COPD) in 2011,
and has shown greater potency based on IC50 values (a non-clinical
measure of a drug's potency) than other 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 and the systemic treatment of plaque
psoriasis.
About the ARQ-151-301 (DERMIS-1) and
ARQ-151-302 (DERMIS-2) Phase 3 ProgramArcutis is currently
conducting a Phase 3 clinical program with topical roflumilast
cream, including two ongoing Phase 3 clinical trials (Studies
ARQ-151-301 and ARQ-151-302) to support registration with the FDA.
The studies, referred to as the “Trials of PDE4
inhibition with Roflumilast for the
Management of Plaque Psoriasis”
(DERMIS-1, DERMIS-2), are identical Phase 3 randomized, parallel,
double-blind, vehicle-controlled, multi-national, multi-center
studies in which 0.3% topical roflumilast cream or vehicle cream
are applied once daily for 8 weeks to subjects aged 2 and above
with mild, moderate or severe chronic plaque psoriasis involving
between 2% and 20% body surface area. The studies will each enroll
approximately 400 patients. 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 half of 2021.
About PsoriasisPsoriasis is a common,
non-contagious, immune-mediated skin disease that affects
approximately 8.6 million patients in the United States.
About 90% of patients with psoriasis have chronic 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. Although uncommonly diagnosed in children
and adolescents, particularly in children under the age of 5,
plaque psoriasis occurs in approximately 0.5% of children and
adolescents.
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 three novel compounds (topical
roflumilast cream, topical roflumilast foam and ARQ-252) for
multiple indications, including psoriasis, atopic dermatitis,
seborrheic dermatitis and eczema. 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 the potential for topical roflumilast to be a
best-in-class topical PDE4 inhibitor; the potential for topical
roflumilast to be approved for plaque psoriasis, including the
potential for approval for use in children; and the anticipated
timing and results from the pivotal Phase 3 trials. 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 Registration Statement on Form S-1 filed with U.S.
Securities and Exchange Commission (SEC) on January 21, 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:John W. SmitherChief Financial
Officerjsmither@arcutis.com
Investors and Media:Heather Rowe ArmstrongVice
President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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