Arcutis Advances Science of Psoriasis Drug Development with New Precision Method for Measuring Mild-to-Moderate Psoriasis
July 21 2021 - 8:00AM
In order to address a major limitation of today’s most widely used
method for gauging severity of plaque psoriasis (the PASI scale),
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), in conjunction
with leading psoriasis experts, has developed a revised scale that
offers greater precision for measuring disease extent and
therapeutic effects in patients with mild-to-moderate disease.
Arcutis, a late-stage biopharmaceutical company that champions
meaningful innovation to address immune-mediated dermatological
diseases and conditions, shared details of the new approach in the
peer-reviewed scientific journal Dermatology and Therapy.
“The majority of people affected by plaque psoriasis experience
mild or moderate disease, yet clinicians lack the best possible
tools to provide an accurate measurement of severity for those
individuals,” said Robert Higham, MPAS, PA-C, Executive Director of
Clinical Development for Arcutis and one of the authors of the
article. “As we work toward bringing topical treatment innovations
for psoriasis to dermatologists and patients, we believe
innovations are likewise needed to improve the tools and methods to
properly diagnose and track all levels of disease and treatment
effects.”
The article notes that disease severity is an essential outcome
measure in clinical trials of new treatments for plaque psoriasis.
However, the most common clinical measure to assess disease
severity—the Psoriasis Area and Severity Index (PASI)—is geared
toward more-severe levels of disease. To determine a PASI score,
the area of body region affected by psoriasis is estimated and
given a number, but for body areas with less than 10 percent of
disease, a non-granular score of 1 is applied regardless of the
actual extent of disease, masking any changes in disease extent
between 0 and 9 percent.
To address this shortcoming, Arcutis has introduced a key
modification to PASI that more accurately measures severity and
evaluates treatment effectiveness for areas of the body with
mild-to-moderate levels of disease. The new method, PASI-high
discrimination (PASI-HD), is designed to be used in clinical trials
among patients for whom the areas of affected body surface within
the anatomical regions measured by PASI are less than 10
percent.
“Other alternatives to the PASI have been proposed in the past,
but no other option preserves the anatomical component of the index
by assessing the severity and percentage of area affected in the
four body regions: head and neck, upper extremities, trunk, and
lower extremities,” said co-author Kim Papp, M.D., Ph.D., a Fellow
of the Royal College of Physicians of Canada and Founder and
President of Probity Medical Research Inc. Papp, a scientific
advisor for Arcutis, also co-authored the journal article.
In addition, PASI-HD more precisely captures disease flaring
from and within areas with less than 10 percent of disease
involvement.
“Even mild or moderate psoriasis significantly impacts quality
of life, and deserves focused attention from the medical
dermatology community,” said Patrick Burnett, M.D., Ph.D., FAAD,
Chief Medical Officer of Arcutis. “As part of our mission to
revitalize the standard of care for dermatological diseases, we
believe it is necessary to remove the challenges that have
traditionally hampered innovation for patients with skin
diseases.”
In addition to Higham and Papp, authors of the article include
colleagues at Arcutis and leading experts in the field of medical
dermatology:
- Mark Lebwohl, M.D., Professor and Chair of the Kimberly and
Eric J. Waldman Department of Dermatology of the Icahn School of
Medicine, Mount Sinai and Arcutis scientific advisor
- Leon Kircik, M.D., Clinical Professor of Dermatology, Icahn
School of Medicine, Mount Sinai, and Medical Director of
DermResearch, PLLC, Physicians Skin Care, PLLC, and Skin
Sciences
- David Pariser, M.D., Senior Physician at Pariser Dermatology
Specialists
- Bruce Strober, M.D., Ph.D., Clinical Professor of Dermatology,
Yale School of Medicine and Co-Founder of Central Connecticut
Dermatology
- Gerald Krueger, M.D., Dermatologist at University of Utah
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 anticipated by the end of 2021 and three more Phase 3
clinical data readouts anticipated over the next 18 months. 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.
Investor Contact:ir@arcutis.com
Media Contact:Amanda Sheldon805.418.5006
x7116asheldon@arcutis.com
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