Arcutis Completes Enrollment in Phase 1/2b Study Evaluating ARQ-252 in Chronic Hand Eczema
October 26 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 completed enrollment in its 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. Arcutis has updated its projections and now
anticipates announcing topline data from this trial by mid-2021.
“We were pleased with the speed with which this
trial enrolled, underscoring the high unmet need for new treatments
to treat this chronic skin disease that can cause significant skin
irritation and discomfort and can have a negative impact on a
patient’s quality of life,” said Patrick Burnett, M.D., Ph.D.,
FAAD, Arcutis’ Chief Medical Officer. “More than eight million
people in the U.S. suffer from hand eczema, and patients often have
to make trade-offs between drug efficacy, safety, and tolerability
with current available treatments. ARQ-252 has demonstrated robust
potency and high selectivity for JAK1 over JAK2, thereby giving it
the potential to deliver efficacy without causing the side effects
typical of other less selective JAK inhibitors. Given this, we
believe ARQ-252 has the potential to reduce the need to compromise
between safety and efficacy.”
In April, Arcutis began the Phase 1 portion of
this 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 seven subjects with chronic hand
eczema. In July, the Company began the Phase 2b portion of the
study to 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. Enrollment of the Phase 2b portion is now
complete with 223 subjects. The Company expects to report topline
data by mid-2021.
About Hand EczemaHand eczema is
a common inflammatory skin disease with prevalence estimated at up
to 2.5% of the population, and is the most common skin disease
affecting the hands. Symptoms of hand eczema can vary 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 2b 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 in patients
with chronic hand eczema. Reistone Biopharma, a subsidiary of
Hengrui, is also studying the oral formulation as a potential
treatment for alopecia areata, Crohn’s disease, ulcerative colitis
and atopic dermatitis.
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
www.arcutis.com or follow the company on LinkedIn and Twitter.
Forward Looking StatementsThis
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
Form 10-Q filed with U.S. Securities and Exchange Commission (SEC)
on August 11, 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 ArmstrongVice President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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