Arcutis Initiates Patient Enrollment in the Phase 2b Portion of the Phase 1/2b Study Evaluating ARQ-252 in Chronic Hand Eczem...
July 13 2020 - 9:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology
company developing innovative treatments for patients with
immune-mediated dermatological diseases and conditions, today
announced that it initiated enrollment in the Phase 2b portion of
the Phase 1/2b study of ARQ-252, a potent and highly selective
topical small molecule inhibitor of Janus kinase type 1 (JAK1), in
adult patients with chronic hand eczema. Topline data from this
trial are expected in the second half of 2021.
“More than eight million people in the U.S.
suffer from hand eczema, a chronic skin disease that can cause
significant skin irritation and discomfort and negatively impact a
person’s quality of life,” said Howard Welgus, M.D., Arcutis’ Chief
Medical Officer. “Current treatments often fall short, resulting in
patients and physicians making trade-offs between efficacy and
tolerability. We are pleased to begin enrollment in this important
study of ARQ-252 in adult patients with chronic hand eczema. We
believe that, due to its demonstrated potency and high selectivity
for JAK1 over JAK2, ARQ-252 has the potential to provide the level
of efficacy patients desperately want without causing the side
effects that may be associated with other less selective JAK
inhibitors, thereby eliminating the need to compromise between
safety, efficacy, and tolerability.”
In April, Arcutis began enrolling patients in
the Phase 1 portion of the Phase 1/2b study to assess the safety,
tolerability, and pharmacokinetics of once daily application of
ARQ-252 cream 0.3% to both hands for two weeks in six subjects with
chronic hand eczema. The Phase 2b portion of this study will assess
the safety and efficacy of ARQ-252 cream 0.1% once daily and
ARQ-252 cream 0.3% once daily or twice daily versus vehicle applied
once daily or twice daily for 12 weeks to patients with chronic
hand eczema. The Company expects topline data in the second half of
2021.
About Hand EczemaHand eczema is
a common inflammatory skin disease with prevalence estimated at up
to 2.5% of the population. Symptoms of hand eczema can vary by
severity and include redness, fluid filled blisters or bumps,
scaling, cracking, itching and pain occurring on the hands. It may
occur in various forms, incorporating dyshidrotic eczema, an immune
disease possibly related to atopic dermatitis; irritant contact
dermatitis of the hands, which may be caused by occupational
irritants; allergic contact dermatitis of the hands, which is
caused by an allergic reaction; atopic hand dermatitis, which is
atopic dermatitis occurring on the hands, and hyperkeratotic hand
dermatitis, which are thickened, scaly, red plaques, similar to
psoriasis, on the hands. The impact of hand eczema on patients can
be significant, leading to work absences or disability, social
stigmatization, and psychosocial distress.
About ARQ-252ARQ-252 is a
potent and highly selective topical, small molecule inhibitor of
Janus kinase type 1 (JAK1). Many inflammatory cytokines and
other signaling molecules rely on the JAK pathway, and specifically
JAK1, which plays a central role in immune system function.
Inhibition of JAK1 has been shown to treat a range of inflammatory
diseases, including rheumatoid arthritis, Crohn’s disease, and
atopic dermatitis. The Company believes that due to its high
selectivity for JAK1 over JAK2, ARQ-252 has the potential to
effectively treat inflammatory diseases without causing the
hematopoietic adverse effects typically associated with JAK2
inhibition. In 2018, Arcutis exclusively licensed the active
pharmaceutical ingredient in ARQ-252 for all topical dermatological
uses in the United States, Europe, Japan and Canada from Jiangsu
Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed
a Phase 2 study in rheumatoid arthritis that used the same active
pharmaceutical ingredient as in ARQ-252 but dosed orally. The
results confirmed that this active pharmaceutical ingredient is a
highly potent inhibitor of JAK1 based on the drug’s impact on
rheumatoid arthritis, and was generally well tolerated at exposures
well above those expected with topical administration of ARQ-252.
Reistone Biopharma, a subsidiary of Hengrui, is also studying the
oral formulation as a potential treatment for alopecia areata.
About Arcutis - Bioscience, applied to the
skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is
a medical dermatology company developing innovative treatments for
patients with immune-mediated dermatological diseases and
conditions. The company is leveraging recent advances in immunology
and inflammation to develop differentiated therapies against
biologically validated targets to solve persistent treatment
challenges in serious diseases of the skin. Arcutis’ robust
pipeline includes four novel drug candidates currently in
development for a range of inflammatory dermatological conditions.
The company’s lead product candidate, topical roflumilast, has the
potential to revitalize the standard of care for plaque psoriasis,
atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.
For more information, visit https://www.arcutis.com or follow
the company on LinkedIn and Twitter.
Forward Looking Statements This press release
contains "forward-looking" statements, including, among others,
statements regarding the potential for ARQ-252 to treat hand eczema
without causing the adverse effects associated with other JAK
inhibitors; and the anticipated timing of the topline data of the
Phase 2b portion of the study. 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 Annual Report on
Form 10-K filed with U.S. Securities and Exchange
Commission (SEC) on March 19, 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.
Investors and Media:Heather Rowe Armstrong Vice
President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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