Arcutis Announces Data Comparing the Vehicle in Investigational Roflumilast Cream Against a Commercial Ceramide-Containing Moisturizing Cream
14 December 2021 - 12:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing meaningful
innovations in immuno-dermatology, today announced data suggesting
that Arcutis’ proprietary cream vehicle had similar moisturizing
properties as a commercially marketed, dermatologist-recommended,
ceramide-containing moisturizer in adults with mild eczema. The
data from the two groups were similar across patient and healthcare
provider assessments of tolerability and aesthetic improvement.
Atopic dermatitis and other forms of eczema have
underlying skin barrier defects, which can be further exacerbated
by topical medications that harm the skin barrier. Arcutis designed
its cream vehicle with both 50% water content and an ultra-mild
emulsifier at PH of the skin, as well as excluding propylene
glycol, polyethylene glycol, ethanol, or fragrance.
“In this study, both the Arcutis cream vehicle and
a dermatologist-recommended, ceramide-containing moisturizing cream
were well received by patients, with patients reporting
improvements in dryness, redness, irritation and other skin
characteristics, as well as positive feedback on the aesthetic
properties of the two creams. As a clinician, I was impressed by
the moisturizing properties of the Arcutis vehicle,” said Zoe Diana
Draelos, MD, President and Principal Investigator, Dermatology
Consulting Services, PLLC.
Data from the 40-patient, single-site, randomized,
double-blinded intraindividual study were presented at the annual
RAD Conference. Patients with mild asteatotic eczema applied either
roflumilast vehicle cream (without the active ingredient
roflumilast) or the ceramide-containing moisturizer to their lower
legs (randomized by leg with each subject receiving the
ceramide-containing moisturizer and the Arcutis cream vehicle on
opposite legs). There was no statistically significant change from
baseline in TEWL at Day 15 with either preparation, suggesting that
no skin barrier damage was caused by either the vehicle or the
moisturizer. TEWL is the most widely-used objective measurement of
skin barrier function and can be used as an objective analysis of
irritancy potential or protective properties of topical products.
Mean TEWL was similar between roflumilast cream vehicle and the
ceramide-containing moisturizer throughout the study after day
1.
Patients rated the Arcutis cream vehicle positively
and as comparable to the ceramide-containing moisturizer.
Specifically, the study found similar improvements in dryness,
redness, roughness, tightness, irritation, moisturization,
smoothness and overall skin appearance between the two products. In
addition, patients consistently rated the aesthetic properties,
including spreadability, speed of absorption, feel of skin, and
smell, comparably between the Arcutis cream vehicle and
ceramide-containing moisturizer. For investigator assessments of
erythema, desquamation, roughness and dryness, improvements were
observed for both treatments at all timepoints.
“Arcutis is dedicated to bringing meaningful
innovation to topicals, where limited innovation has occurred for
many years. With six dermatology clinicians on staff, as well as
one of the industry’s leading topical formulators, founder David
Osborne, we have invested in developing therapies that may help
address the trade-offs typically seen with many topical dermatology
products,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical
Officer at Arcutis.
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 multiple clinical programs
for a range of inflammatory dermatological conditions, with one NDA
submitted to the FDA and three Phase 3 clinical data readouts
anticipated by the end of 2022. The company’s lead program, 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 Statements This press
release contains "forward-looking" statements, including, among
others, statements regarding the potential for roflumilast to be
approved for the treatment of, and to advance the standard of care
for, adults and adolescents with atopic dermatitis, 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 our 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:
Media Amanda Sheldon, Head of
Corporate Communications asheldon@arcutis.com
Investors Eric McIntyre, Head of
Investor Relations emcintyre@arcutis.com
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