Data from Long-Term Safety Study Support Chronic Use of ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Pla...
December 01 2020 - 4:05PM
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
positive results for the Phase 2 long-term safety study evaluating
ARQ-151 (topical roflumilast cream) 0.3% as a potential once-daily
chronic topical treatment for plaque psoriasis.
The long-term safety study enrolled 332
patients, including one cohort (Cohort 1) of patients who elected
to continue open-label treatment (n=230) following their
participation in the double-blind, randomized Phase 2b study of
roflumilast cream in plaque psoriasis, the results from which were
published in the New England Journal of Medicine, and second cohort
(Cohort 2) of treatment naïve patients (n=102). The maximum
duration of treatment ranged from 52 weeks for naïve patients and
those treated with vehicle in the randomized Phase 2b study, to 64
weeks for those treated with roflumilast cream for 12 weeks in the
randomized Phase 2b study. In this open-label study, roflumilast
cream 0.3% applied once daily for up to 52 weeks demonstrated
favorable safety and tolerability over the long-term treatment
period, consistent with what was seen in the randomized Phase 2b
study, with only 3.6% of patients experiencing a treatment-related
adverse event during 52 weeks of treatment. At week 52 of the
long-term safety study, 44.8% of all subjects attained an
Investigator Global Assessment (IGA) of clear or almost clear, with
34.8% of subjects in Cohort 1 and 39.5% of subjects in Cohort 2
achieving IGA Success, defined as a score of clear or almost clear
plus a two-grade improvement from baseline. Additionally, of the
subjects in the 12 week randomized Phase 2b study who were treated
with roflumilast cream 0.3%, and who attained an IGA of clear or
almost clear at 12 weeks in the first study, then continued on
treatment in the long-term safety study, 66.7% had an IGA of clear
or almost clear at the end of 64 weeks of treatment or their last
visit. Of the 332 subjects in this study, 73.5% completed the full
52 weeks of open label treatment, with only 3.9% of subjects
discontinuing the study due to an adverse event and less than 1% of
subjects discontinuing due to lack of efficacy. There were no
treatment related serious adverse events reported.
“We are delighted with the results from this
study of patients receiving long-term treatment with roflumilast
cream, which support our belief that roflumilast cream, unlike high
potency steroids, can be used chronically,” said Patrick
Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “We are
encouraged that the efficacy and tolerability seen in this
long-term study are consistent with the results seen in the
double-blind Phase 2b study, and the unusually high proportion of
patients who completed the full 52 weeks of treatment bodes well
for real-world patient persistence. We believe there is a
significant unmet need from patients and their dermatologists, who
for too long have been forced to make trade-offs between efficacy,
safety, and tolerability due to the significant shortcomings of
existing topical treatments for psoriasis. Based on the strength of
our clinical data to date, we believe that topical roflumilast has
the potential to offer an ideal combination of efficacy comparable
to a high potency steroid, the ability to use the drug chronically
in any anatomical area, and a favorable safety and tolerability
profile. We are hopeful that topical roflumilast, if approved, will
help dermatologists and their patients to overcome these difficult
clinical compromises. We look forward to the results from the
ongoing DERMIS-1 and DERMIS-2 Phase 3 clinical trials of ARQ-151 in
plaque psoriasis, which are anticipated in the first quarter of
next year.”
The roflumilast cream long-term safety study was
a Phase 2, multi-center, open label study of the long-term safety
and efficacy of roflumilast cream 0.3% in adult subjects with
chronic plaque psoriasis involving up to 25% total body surface
area (BSA), evaluated in two cohorts: subjects who completed the
ARQ-151-201 Phase 2b, randomized, controlled trial; and previously
untreated subjects. Subjects applied roflumilast cream 0.3% once
daily for 52 weeks at home. Approximately half (164 out of 332) of
the subjects entered this long-term study after completing
treatment with roflumilast cream 0.3% or 0.15% in the randomized
Phase 2b study and therefore received up to 64 weeks of total
treatment with topical roflumilast (12 weeks in the randomized
Phase 2b study and 52 weeks in the long-term safety study).
Periodic clinic visits included assessments for clinical safety,
application site reactions, and disease improvement or progression.
The primary outcome measures of this long-term safety study were
the occurrence of treatment emergent adverse events and the
occurrence of serious adverse events.
Roflumilast cream is a once-daily topical cream
formulation of a highly potent and selective PDE4 inhibitor
(roflumilast). Roflumilast has been approved by the U.S. Food and
Drug Administration (FDA) for systemic treatment to reduce the risk
of exacerbations of chronic obstructive pulmonary disease (COPD)
since 2011. Roflumilast has shown greater potency (25-to 300-fold)
than the two other FDA-approved PDE4 inhibitors. 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 FDA for the topical treatment
of atopic dermatitis or the systemic treatment of plaque
psoriasis.
About PsoriasisPsoriasis is a
common, non-contagious, immune disease that affects approximately
8.6 million patients in the United States and requires chronic
treatment. About 90% of psoriasis cases are plaque psoriasis, which
is characterized by 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 regions such as the groin, axillae and
inframammary areas.
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
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 of roflumilast
cream to address the unmet needs in the topical treatment of
psoriasis; the potential safety and efficacy of roflumilast cream;
and the timing of clinical data readouts. 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 November 5, 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.
Contact:Heather Rowe
ArmstrongVice President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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