Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255
06 December 2022 - 12:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced the
first subject has been enrolled in a Phase 1b study evaluating
ARQ-255, a topical suspension of ivarmactinib, a potent and
specific janus kinase 1 (JAK1) inhibitor, for the treatment of
alopecia areata. ARQ-255 has been specifically formulated with
Arcutis’ proprietary 4D technology to deliver drug deep into the
skin to the base of the hair follicle, the site of the inflammation
that underlies alopecia areata.
“Alopecia areata is an immune condition that not only causes
hair loss, but also causes significant negative impact on an
individual’s emotional and mental wellbeing. Today, there are no
FDA-approved topical therapies to treat the condition,” said Frank
Watanabe, President and CEO at Arcutis. “We are delighted to take
this first step in the clinical development of ARQ-255, which
leverages our unique 4D technology to deliver drug to the site of
inflammation deep in the hair follicle.”
The phase 1b, vehicle-controlled, double-blind, multicenter
study will evaluate the safety, tolerability, and pharmacokinetics
of treatment with ARQ-255 topical suspension 3% or vehicle in
healthy adult volunteers and individuals with patchy alopecia
areata.
About ARQ-255ARQ-255, or topical invarmactiniib
suspension, is a topical janus kinase 1 (JAK1) inhibitor therapy
for alopecia areata. Topical treatment of alopecia areata is
challenging due to the depth of inflammation and the dense
vasculature that surrounds the hair bulb. ARQ-255 has been uniquely
formulated to deliver drug deeper into the skin than conventional
topical formulations, to reach the site of inflammation
in alopecia areata.
About Alopecia AreataAlopecia areata is an
autoimmune condition that affects about 1 in 500 adults and occurs
in individuals of all ages, sexes, and ethnic groups. In alopecia
areata, the immune system attacks the body’s own hair
follicles—leading to the development of patches of hair loss
(alopecia) on the scalp, face, and other areas of the body.
Typically, these bald patches appear suddenly and in some patients
can progress to involve the entire body. Recurrence is common and
many patients will experience several episodes during their
lifetime.
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is a medical dermatology company that champions
meaningful innovation to address the urgent needs of individuals
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 including scalp psoriasis,
atopic dermatitis, and seborrheic dermatitis. For more information,
visit www.arcutis.com or follow Arcutis on LinkedIn,
Facebook, and Twitter.
Forward-Looking StatementsArcutis cautions you
that statements contained in this press release regarding matters
that are not historical facts are forward-looking statements. These
statements are based on the Company’s current beliefs and
expectations. Such forward-looking statements include, but are not
limited to, statements regarding the potential for ARQ-255 as a
treatment for alopecia areata. These statements are subject to
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. Risks and uncertainties that may cause our actual
results to differ include risks inherent in our business,
reimbursement and access to our products, the impact of competition
and other important factors discussed in the "Risk Factors" section
of our Form 10-K filed with U.S. Securities and Exchange Commission
(SEC) on February 22, 2022, as amended, as well as any subsequent
filings with the SEC. You should not place undue reliance on any
forward-looking statements in this press release. We undertake no
obligation to revise or update information herein to reflect events
or circumstances in the future, even if new information becomes
available. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
Contacts:MediaAmanda Sheldon,
Head of Corporate Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@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