Arcutis Announces Enrollment of First Patient in Topical Roflumilast Cream Phase 3 Open Label Extension Study in Plaque Psor...
February 13 2020 - 8:30AM
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, today announced it
has enrolled the first patient in an open label extension study,
DERMIS-OLE, evaluating topical roflumilast cream (ARQ-151) as a
potential treatment for plaque psoriasis. Roflumilast cream,
Arcutis’ lead product candidate, is a highly potent and selective
phosphodiesterase type 4 inhibitor (“PDE4 inhibitor”) once-daily
topical cream.
Howard Welgus, M.D., Arcutis’ Chief Medical
Officer, commented: “Psoriasis can be difficult to treat with
topical agents, which are often limited by inadequate efficacy,
poor safety and tolerability, or both. In clinical trials,
topical roflumilast cream has demonstrated an efficacy and
tolerability profile that may offer meaningful improvements over
existing topical treatments to patients with plaque psoriasis. We
are conducting a Phase 3 program with roflumilast cream, including
two registrational Phase 3 studies in plaque psoriasis called
DERMIS-1 and DERMIS-2, and intend to use the results from the
DERMIS open label extension study to support potential
recommendations for long-term use of roflumilast cream in patients
with this chronic disease. We believe roflumilast cream has the
potential to be a once daily treatment that benefits patients with
plaque psoriasis who currently lack suitable treatment
options.”
Topical roflumilast cream (ARQ-151) contains the
highly potent and selective phosphodiesterase type 4 (PDE4)
inhibitor roflumilast, which has been approved globally for the
systemic treatment of chronic obstructive pulmonary disease (COPD)
since 2011 and which is many-fold more potent than any other
disclosed PDE4 inhibitor. PDE4 is an intracellular enzyme that
increases the production of pro-inflammatory mediators and
decreases production of anti-inflammatory mediators, and has been
implicated in a wide range of inflammatory diseases including
psoriasis, eczema, and COPD. PDE4 is an established target in
dermatology, and other PDE4 inhibitors have been approved by the
U.S. Food and Drug Administration (FDA) for the topical treatment
of atopic dermatitis and the systemic treatment of plaque
psoriasis.
DERMIS-OLE Open Label Extension Study
(ARQ-151-306)Up to 250 subjects who completed 8 weeks of
the double-blind treatment in the company’s Phase 3 DERMIS-1 or
DERMIS-2 studies are eligible to roll over to the DERMIS-OLE open
label extension study. In this study, all subjects will receive
0.3% topical roflumilast cream for 24 weeks. The primary endpoints
of this study will be the occurrence of Treatment-Emergent Adverse
Events (TEAEs) and the occurrence of Serious Adverse Events
(SAEs).
Phase 3 Program: ARQ-151-301 (DERMIS-1)
and ARQ-151-302 (DERMIS-2)Arcutis is currently conducting
a Phase 3 clinical program with topical roflumilast cream,
including two ongoing Phase 3 clinical trials (Studies ARQ-151-301
and ARQ-151-302) to support registration with the FDA. The studies,
referred to as the “Trials of PDE4 inhibition with
Roflumilast for the Management of
Plaque Psoriais” (DERMIS-1, DERMIS-2), are
identical Phase 3 randomized, parallel, double-blind,
vehicle-controlled, multi-national, multi-center studies in which
0.3% topical roflumilast cream or vehicle cream are applied once
daily for 8 weeks to subjects aged 12 and above with mild, moderate
or severe chronic plaque psoriasis involving between 2% and 20%
body surface area. The studies will each enroll approximately 400
patients. The primary endpoint of the studies is Investigator
Global Assessment (IGA) Success, defined as an IGA score of clear
or almost clear and at least a 2-grade improvement from baseline at
week 8 on the IGA score. Multiple secondary endpoints will also be
evaluated, including Intertriginous IGA (I-IGA) Success, and
improvements in Psoriasis Area Severity Index (PASI), itch as
measured by the Worst Itch-Numerical Rating Scale (WI-NRS) and
patient perceptions of symptoms as measured by the Psoriasis
Symptoms Diary (PSD). The company anticipates topline data from the
Phase 3 studies in the first half of 2021.
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 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. Arcutis exploits recent
innovations in inflammation and immunology to develop potential
best-in-class therapies against validated biological targets,
leveraging our deep development, formulation and commercialization
expertise to bring to market novel dermatology treatments, while
maximizing our probability of technical success and financial
resources. Arcutis is currently developing three novel
compounds (topical roflumilast cream (ARQ-151), topical roflumilast
foam (ARQ-154) and ARQ-252) for multiple indications, including
psoriasis, atopic dermatitis, seborrheic dermatitis and eczema. For
more information, please visit www.arcutis.com or follow the
Company on LinkedIn.
Contact:John W. SmitherChief Financial
Officerjsmither@arcutis.com
Investors and Media:Derek Cole,
PresidentInvestor Relations Advisory
Solutions720.785.4497derek.cole@IRadvisory.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/4aafa010-32a2-4c34-9b65-3d49e478e752
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