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 reported new
positive data from previously announced Phase 2 studies of ARQ-151
(topical roflumilast cream) in patients with chronic plaque
psoriasis and atopic dermatitis. The data is being presented at the
European Academy of Dermatology and Venereology (EADV) Virtual
Congress (EADV Virtual), Society of Dermatology Physician
Assistants (SPDA) Digital 2020 conference, and virtual 2020 Fall
Clinical Dermatology Conference.
Roflumilast cream, a potent phosphodiesterase-4 (PDE-4)
inhibitor, is being investigated as a once-daily topical treatment
for chronic plaque psoriasis and atopic dermatitis. In two virtual
presentations, Arcutis shared data from a Phase 2b study on the
efficacy of roflumilast cream on itch, a highly prevalent and
frequently bothersome symptom of chronic plaque psoriasis, and on
improving the burden of typical plaque psoriasis symptoms. In a
third presentation, Arcutis highlighted results from a Phase 2
proof-of-concept study on the short-term safety and efficacy of
roflumilast cream in patients with mild-to-moderate atopic
dermatitis.
“The results from our Phase 2 studies highlight the potential of
roflumilast cream as a best-in-class topical PDE4 inhibitor for
chronic plaque psoriasis and atopic dermatitis,” said Patrick
Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “The
Phase 2b psoriasis study data provide clinical evidence of
roflumilast cream’s ability to reduce the burden of itch and
improve typical symptoms in patients with plaque psoriasis. In
addition, the encouraging efficacy results and safety profile in
our Phase 2 proof-of-concept of roflumilast cream in atopic
dermatitis provide a solid foundation for our upcoming pivotal
Phase 3 studies.”
Results from the Phase
2b Study in Plaque Psoriasis
In the Phase 2b study, 331 patients were randomized to
roflumilast 0.3% (n=109), roflumilast 0.15% (n=113), or vehicle
(n=109). At baseline, patients had to score ≥2 on the Investigator
Global Assessment (IGA) scale and ≥2 on the modified Psoriasis Area
and Severity Index. The primary endpoint was achievement of clear
or almost clear skin based on IGA 0 or 1 at Week 6.
Itch was assessed at baseline and throughout the 12-week trial
using various patient-reported outcome measures, including itch
severity and itch-related sleep loss. The study showed that
treatment with roflumilast cream resulted in a rapid and clinically
significant reduction in the severity and burden of itch compared
to vehicle. In the roflumilast 0.3% group, significant itch
reduction occurred by week 2 as compared with vehicle and continued
through week 12 with 63% of patients achieving a clinically
meaningful itch reduction. Reduction in itch also resulted in
significant improvement in sleep loss by week 6 and continued
through week 12.
The Phase 2b study also assessed the efficacy of roflumilast
cream in improving the burden of signs and symptoms of plaque
psoriasis, including stinging, burning, skin cracking, pain, and
scaling. Both doses of once-daily roflumilast cream led to rapid
and robust improvements in symptom burden and quality of life in
the patient population. The study results showed statistically
significant improvements for both roflumilast doses compared with
vehicle were seen in burden of individual patient-reported
psoriasis-related signs and symptoms of scaling by Week 2;
stinging, skin cracking, and pain by Week 4; and burning by Week 6.
All reported improvements in individual psoriasis-related signs and
symptoms were maintained through Week 12 with a mean decrease from
baseline in the overall Patient Symptom Diary (PSD) Score of 42 and
44 in the roflumilast 0.3% and 0.15% groups, respectively.
Roflumilast cream was well-tolerated by patients in the Phase 2b
study. The rate of application site pain was low and similar to
vehicle. 97% of adverse events were mild or moderate.
Results from the Phase
2 Proof-of-Concept Study in Atopic Dermatitis
In the Phase 2 proof-of-concept study in atopic dermatitis (AD),
136 patients were randomized to roflumilast 0.15%, roflumilast
0.05% or vehicle once-daily for 4 weeks. Patients had 1.5–35% body
surface area (BSA) affected by AD, with a validated investigator
global assessment AD (vIGA-AD) score of 2 (mild) or 3 (moderate),
and eczema area and severity index (EASI) score of ≥5. The primary
efficacy endpoint was absolute change from baseline in EASI score
at Week 4.
Study results showed that once-daily roflumilast cream
demonstrated efficacy when compared to vehicle in AD. Although the
primary endpoint in this proof of concept study showed a trend
towards, but did not reach statistical significance, statistical
significance for other efficacy endpoints was reached.
Statistically significant improvements compared with vehicle were
observed at Week 4, including 72.3% EASI improvement and >50% of
patients achieving clear or almost clear skin on vIGA-AD for
roflumilast cream 0.15%. Roflumilast cream was well tolerated, with
a low rate of application site reactions, and no local
irritation.
The virtual presentations of Arcutis’ Phase 2b and Phase 2
proof-of-concept studies of roflumilast cream given at the EADV
Virtual Congress (October 29-31, 2020) and the 2020 Fall Clinical
Dermatology Conference and SPDA DIGITAL 2020 (October 29 – November
1, 2020), are available for on-demand viewing using the links below
and under Scientific Publications on the Arcutis website:
- Roflumilast Cream (ARQ-151) Improved
Itch Severity and Itch-related Sleep Loss in Adults With Chronic
Plaque Psoriasis in a Phase 2b Study: EADV Virtual
Congress; 2020 Fall
Clinical; SPDA DIGITAL
2020
- Roflumilast Cream (ARQ-151) 0.15%
and 0.3% Improved Symptom Burden in Adults With Chronic Plaque
Psoriasis in a Phase 2b Study: EADV Virtual
Congress; 2020 Fall
Clinical; SPDA DIGITAL
2020
- The Safety and Efficacy of
Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2
Proof-of-Concept Study: EADV Virtual
Congress; 2020 Fall
Clinical; SPDA DIGITAL
2020
About Atopic Dermatitis
Atopic dermatitis (AD) is the most common type of eczema,
occurring in approximately six percent of the U.S. population. AD
is characterized by a defect in the skin barrier, which allows
allergens and other irritants to enter the skin, leading to an
immune reaction and inflammation. This reaction produces a red,
itchy rash, most frequently occurring on the face, arms and legs,
and the rash can cover significant areas of the body, in some cases
half of the body or more. Disease onset is most common by 5 years
of age, and the Company estimates that approximately 60% of
patients suffering from AD are pediatric patients. The rash causes
significant pruritus (itching), which can lead to skin damage
caused by scratching or rubbing. Given that most of the patients
are pediatric, the safety and tolerability of AD therapies are
paramount.
About Psoriasis
Psoriasis is a common, non-contagious, immune-mediated skin
disease that affects approximately 8.6 million patients in the
United States. About 90% of patients develop 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 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 Statements
This press release contains "forward-looking" statements,
including, among others, statements regarding ARQ-151’s potential
as a “Best-in-Class” PDE4 inhibitor, ARQ-151’s potential as a
treatment for atopic dermatitis, ARQ-151’s potential as a treatment
for plaque psoriasis and whether positive results in Phase 2
studies are indicative of potential outcomes in future studies.
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 Armstrong
Vice President, Investor Relations & Corporate
Communications
harmstrong@arcutis.com
805-418-5006, Ext. 740
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