The Journal of Drugs in Dermatology Publishes Results from Positive Phase 1/2a Trial of Arcutis’ ARQ-151 (Topical Roflumila...
August 03 2020 - 8:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing and commercializing
treatments for unmet needs in immune-mediated dermatological
diseases and conditions, or immuno-dermatology, announced today
that The Journal of Drugs in Dermatology has published positive
results from a Phase 1/2a trial of its investigational drug topical
roflumilast cream for the treatment of chronic plaque psoriasis.
The article has been published in the August 2020 issue of the
journal. These results demonstrate that ARQ-151 (roflumilast cream)
was safe and highly effective at doses of 0.5% and 0.15%, and
represents a potential novel once-daily topical therapy for the
treatment of chronic plaque psoriasis.
“Psoriasis imposes a high burden for patients,
and current standards of care to treat this skin disease often
carry significant treatment limitations, resulting in poor
outcomes. Poor outcomes often have a negative impact on patient
quality of life,” said Kim A. Papp, MD, PhD, of Probity Medical
Research and K. Papp Clinical Research Inc., and lead author of the
publication. “Roflumilast once-daily cream demonstrated significant
improvements in psoriasis signs and symptoms. Notably, roflumilast
cream demonstrated favorable tolerability, without any patient
discontinuation due to adverse events. The positive results from
this study are encouraging for patients and clinicians who are
desperate for a new topical treatment solution that will simplify
disease management and improve the patient experience. Enabling
patients with more effective chronic treatment in all areas of the
body is our hope.”
Roflumilast cream (ARQ-151) is a once-daily,
highly potent, selective phosphodiesterase-4 (PDE-4) inhibitor
being developed for chronic plaque psoriasis. Arcutis is currently
conducting a Phase 3 clinical program with topical roflumilast
cream, including two ongoing pivotal Phase 3 clinical trials
(DERMIS-1 and -2). The company anticipates topline data from the
Phase 3 studies in the first half of 2021.
The Phase 1/2a study assessed the safety and
efficacy of once-daily roflumilast cream 0.5% and 0.15% in patients
with chronic plaque psoriasis. The study enrolled a single-dose,
open-label Phase 1 cohort (0.5% cream applied to 25 cm2 psoriatic
plaques), and a 28-day, double-blinded Phase 2a cohort (1:1:1
randomization to roflumilast cream 0.5%, 0.15%, or vehicle).
Patients had chronic plaque psoriasis of > 6 months’ duration
with ≤5% body surface area involvement. Outcomes included safety
(adverse events) and efficacy (percentage change in the product of
Target Plaque Severity Score [TPSS] and Target Plaque Area [TPA])
at week 4.
For Cohorts 1 (n=8) and 2 (n=89), adverse events
(all mild/moderate; none serious or severe) were similar between
active arms and vehicle. Treatment-related events were confined to
the application site, with no difference between active and
vehicle. No patient discontinued treatment due to adverse events.
The primary efficacy endpoint was met for both roflumilast cream
doses: TPSS×TPA improvement at week 4 was statistically significant
for roflumilast 0.5% (P=0.0007) and 0.15% (P=0.0011) versus
vehicle; significance was reached as early as 2 weeks. For both
roflumilast cream doses, 66% to 67% improvement from baseline was
observed at week 4, without reaching a plateau, versus 38%
improvement for vehicle.
“The results from this Phase 1/2a study provide
further evidence of the potential of roflumilast cream as a
once-daily treatment for patients with plaque psoriasis who
currently lack suitable treatment options, and who often have to
settle for trade-offs in drug efficacy, safety, and tolerability,”
said Frank Watanabe, Arcutis’ President and Chief Executive
Officer. “We believe that topical roflumilast has the potential to
deliver the efficacy that enables meaningful symptomatic
improvement and a safety and tolerability profile that supports
chronic use and the ability to use in all body areas.”
Please refer to the paper, “Roflumilast Cream
Improves Signs and Symptoms of Plaque Psoriasis: Results from a
Phase 1/2a Randomized, Controlled Study” for the full description
of the design and results of this study.
About ARQ-151 (Topical Roflumilast
Cream)Topical roflumilast cream is a once-daily, topical
cream formulation containing roflumilast, a PDE4 inhibitor, that
Arcutis is developing to treat plaque psoriasis, including
intertriginous psoriasis, and atopic dermatitis. PDE4 is an
intracellular enzyme that regulates pro-inflammatory and
anti-inflammatory cytokine production and cell proliferation.
Roflumilast was approved by the FDA for systemic treatment to
reduce risk of exacerbation of chronic obstructive pulmonary
disease (COPD) in 2011, has shown greater potency (25 - 300 fold)
than other two FDA-approved PDE4 inhibitors used in
dermatology.
About PsoriasisPsoriasis is an
immune disease that occurs in about two percent of adults in
western countries. About 90% of psoriasis cases is plaque
psoriasis, which is characterized by “plaques”, or raised, red
areas of skin covered with a silver or white layer of scale.
Psoriatic plaques can appear on any area of the body, but most
often appear on the scalp, knees, elbows, trunk, and limbs, and the
plaques are often itchy and sometimes painful. Plaques in certain
anatomical areas present particular treatment challenges, including
the face, elbows and knees, scalp, and intertriginous areas (where
two skin areas may touch or rub together).
About Arcutis - Bioscience,
applied to the skin.Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is
a late-stage biopharmaceutical company focused on developing and
commercializing treatments for unmet needs in immune-mediated
dermatological diseases and conditions, or immuno-dermatology. 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.
Contacts:Investor
Relations:Heather Rowe ArmstrongVice President, Investor
Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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