New Topical Roflumilast Data Presented at the European Academy of Dermatology and Venereology (EADV) Congress
September 27 2021 - 8:05AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing meaningful
innovations in immuno-dermatology to address the urgent needs of
patients living with immune-mediated dermatological diseases and
conditions, today announced that four abstracts for Arcutis’
topical roflumilast program in psoriasis, scalp and body psoriasis,
and seborrheic dermatitis will be presented at European Academy of
Dermatology and Venereology (EADV) Congress. Topical roflumilast is
a selective and highly potent phosphodiesterase-4 inhibitor being
investigated by Arcutis as a non-steroidal topical treatment for
multiple inflammatory skin diseases.
“Data continue to demonstrate that topical roflumilast delivers
superior efficacy over vehicle across multiple indications while
improving the severity and impact of itch,” said Patrick Burnett,
M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. “We are proud of
the strength of our drug development platform, as demonstrated here
with multiple presentations from our DERMIS pivotal trials in
psoriasis, as well as Phase 2 data in seborrheic dermatitis, and
scalp and body psoriasis.”
New data from the DERMIS-1 and DERMIS-2 Phase 3 pivotal trial
will be presented in the following oral presentation:
Title: Roflumilast Cream 0.3%
Improved the Severity and Impact of Itch in Patients with Chronic
Plaque Psoriasis in the Phase 3 DERMIS-1 and DERMIS-2
StudiesPresenting Author: Dr. Melinda J. GooderhamTime:
2:50 – 3:00 pm CEST/ 8:50 – 9:00 am EDTLocation: Room 13
The presentation will include patient-reported outcomes,
including itch, which patients with plaque psoriasis report as the
most burdensome symptom.
In addition, the following posters will be electronically
available for the entirety of the conference:
Title: Once-Daily Roflumilast
Cream 0.3%, a Potent Phosphodiesterase-4 Inhibitor, Provided Safe
and Effective Treatment of Psoriasis in the DERMIS-1 and DERMIS-2
Phase 3 TrialsPresenting Author: Dr. Mark Lebowohl
Title: Once-daily Roflumilast
Foam 0.3% Improves Severity and Burden of Itch in Patients with
Scalp and Body Psoriasis in a Randomized, Double-blind,
Vehicle-controlled Phase 2b StudyPresenting Author: Dr
Angela Y. Moore
Title: Randomized,
Double-blind, Vehicle-controlled Phase 2a Study Evaluating Once
Daily Roflumilast Foam 0.3% in Patients with Moderate to Severe
Seborrheic DermatitisPresenting Author: Dr. Matthew
Zirwas
About Topical RoflumilastArcutis is developing
topical cream and foam formulations of roflumilast – a highly
potent and selective phosphodiesterase-4 (PDE4) inhibitor being
investigated as a once-daily, nonsteroidal, topical treatment for
multiple dermatologic conditions. 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 ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is a medical dermatology company that champions
meaningful innovation to address the urgent needs of patients
living with immune-mediated dermatological diseases and conditions.
With a commitment to solving the most persistent patient challenges
in dermatology, Arcutis harnesses our unique dermatology
development platform coupled with our dermatology expertise to
build differentiated therapies against biologically validated
targets. Arcutis’ dermatology development platform includes a
robust pipeline with seven clinical programs for a range of
inflammatory dermatological conditions, with our first NDA
submission late in the third quarter or early in the fourth quarter
of 2021 and three more Phase 3 clinical data readouts anticipated
by the end of 2022. The company’s lead product candidate, topical
roflumilast, has the potential to advance the standard of care for
plaque psoriasis, atopic dermatitis, scalp psoriasis, and
seborrheic dermatitis. For more information,
visit www.arcutis.com or follow Arcutis
on LinkedIn and Twitter.Forward-Looking
StatementsThis press release contains "forward-looking"
statements, including, among others, statements regarding the
potential for roflumilast to revolutionize the standard of care in
plaque psoriasis and other inflammatory dermatological conditions.
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-K filed with U.S. Securities and Exchange
Commission (SEC) on February 16, 2021, 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.
Contacts:MediaAmanda Sheldon,
Head of Corporate Communications(805)
418-5006asheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relations(805) 418-5006emcintyre@arcutis.com
Arcutis Biotherapeutics (NASDAQ:ARQT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Arcutis Biotherapeutics (NASDAQ:ARQT)
Historical Stock Chart
From Apr 2023 to Apr 2024