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 New England Journal of Medicine has published positive
results from a Phase 2b trial of its investigational drug topical
roflumilast cream for the treatment of chronic plaque psoriasis.
The article has been published in the July 16 issue of the journal.
These results demonstrate that ARQ-151 (roflumilast cream)
administered once daily was superior to a matching vehicle in
treating psoriasis, as measured by a rating of clear or almost
clear at week six on the Investigator Global Assessment (IGA)
scale.
“Plaque psoriasis imposes a significant burden
on patients, and is often associated with poor quality of life.
Effectively treating psoriasis with topical therapies, which
the vast majority of patients receive, is especially challenging
due to side effects, tolerability or efficacy of existing topical
treatments,” said Mark Lebwohl, MD, Waldman Professor and Chair of
the Kimberly and Eric J. Waldman Department of Dermatology at the
Icahn School of Medicine at Mount Sinai, and the lead author of the
publication. “These data demonstrate that once-daily topical
roflumilast cream was well-tolerated and achieved early and
significant improvements in psoriasis signs and symptoms, including
in the hard-to-treat intertriginous areas such as the armpit or
groin, where two skin surfaces touch.”
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 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 positive results from this study are
particularly encouraging for patients who need new and better
options to treat this chronic skin disease. Roflumilast once-daily
cream demonstrated significant improvements in psoriasis signs and
symptoms,” said Dr. Linda Stein Gold, Director of Dermatology
Clinical Research and Division Head of Dermatology at the Henry
Ford Hospital in Detroit, Michigan, and an investigator in the
study. “The results demonstrated statistical significance in an
investigator determination of clear or almost clear as well as
improvement in patient-reported measures, such as itch and burden
of disease. Additionally, notable efficacy was demonstrated as
early as within two weeks and topical roflumilast cream was
well-tolerated throughout the study.”
In the Phase 2b, double-blinded trial, a total
of 331 adults with plaque psoriasis were randomly assigned in a
1:1:1 ratio to receive topical treatment with roflumilast cream
0.3%, 0.15%, or matching vehicle applied once daily for 12 weeks.
109 patients were treated with roflumilast cream 0.3%, 113 with
0.15% cream, and 109 with the vehicle. The primary efficacy outcome
was Investigator Global Assessment (IGA, a 5-item scale assessing
plaque thickening, scaling, and erythema, ranging from 0-clear to
4-severe) of clear or almost clear at week 6. Secondary outcomes
included clear or almost clear plus a 2-grade improvement (IGA
Success), IGA Success on an Intertriginous IGA, and change in
Psoriasis Area and Severity Index (PASI).
The primary efficacy endpoint of an IGA score
indicating clear or almost clear at Week 6 was 28 percent, 23
percent and 8 percent for roflumilast 0.3%, roflumilast 0.15% and
vehicle (p<0.001 and p=0.004, vs vehicle for roflumilast 0.3%
and 0.15%, respectively). The secondary endpoint of an IGA
score indicating clear or almost clear plus 2-grade improvement
from baseline demonstrated that patients treated with both
roflumilast doses showed separation from vehicle from Week 6
through Week 12, with Week 12 rates of 31% and 27% for roflumilast
0.3% and 0.15%, respectively, vs 14% for vehicle. Among the
approximately 15% of patients with baseline intertriginous
psoriasis of at least mild severity, 14 of 15 (93%) patients
treated with roflumilast 0.3% had an Intertriginous-IGA score of 0
(clear) at Week 12 compared with 3 of 17 (18%) patients in the
vehicle group. At Week 12, PASI-75 response rates
(improvements in PASI from baseline of at least 75%) were 34% for
roflumilast 0.3% vs 16% for vehicle. Application site reactions
were less common in the roflumilast cream arms than the vehicle
arm. Adverse events were reported in 39 percent, 27 percent and 30
percent of patients receiving roflumilast 0.3%, 0.15%, and vehicle,
respectively. Ninety-seven percent of adverse events were rated
mild or moderate in severity. In addition, 94 percent of patients
completed the trial in the roflumilast 0.3% arm.
“The results from this Phase 2b 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,” said Frank Watanabe,
Arcutis’ President and Chief Executive Officer. “We are pleased to
share these results, which suggest topical roflumilast was well
tolerated and efficacious, with the broader scientific community in
such a prestigious journal.”
Please refer to the paper, “Trial of Roflumilast
Cream for Chronic Plaque Psoriasis” 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, and 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
Media Relations: Mike BeyerSam Brown,
Inc.mikebeyer@sambrown.com312-961-2502
Phase 2B Trial of Roflumilast Cream (ARQ-151) for the Treatment
of Chronic Plaque
Psoriasis: http://ml.globenewswire.com/Resource/Download/6a25f0f8-31fc-439d-bcf8-13f6e9514e0b
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