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 top line data from its Phase 2b clinical trial evaluating
ARQ-154 (topical roflumilast foam) as a potential treatment for
scalp psoriasis.
Roflumilast foam 0.3% administered once daily
for 8 weeks demonstrated statistically significant improvements
compared to a matching vehicle foam on key efficacy endpoints in
304 adult and adolescent patients with plaque psoriasis that
included plaques on the scalp. On the study’s primary endpoint of
Scalp Investigator Global Assessment (S-IGA) success assessed at
week 8, roflumilast foam 0.3% achieved a rate of 59.1% compared to
a vehicle rate of 11.4% (p<0.0001). S-IGA success is defined as
the achievement of an S-IGA score of 'clear' or 'almost clear' on a
5-grade scale plus at least a two-point change from
baseline. Onset was rapid, with significantly higher
rates of S-IGA success noted as early as 2 weeks.
Multiple secondary endpoints were also met. On
the key secondary endpoint of Body Investigator Global Assessment
(B-IGA) success assessed at week 8, roflumilast foam 0.3% achieved
a rate of 40.3% compared to a vehicle rate of 6.8% (p<0.0001),
with separation from vehicle on B-IGA success as early as 2 weeks.
Symptomatic improvement was also demonstrated, with 71.0% of
subjects treated with roflumilast foam 0.3% who had a baseline
Scalp Itch Numeric Rating Scale (SI-NRS) score of 4 or greater
achieving an itch reduction of at least 4 points at week 8 compared
to 18.5% of vehicle treated subjects (p<0.0001). Consistent with
other clinical trials of topical roflumilast, roflumilast foam was
well-tolerated, as evidenced by subject-reported local tolerability
and rates of application site adverse events, treatment-related
adverse events, and discontinuations due to adverse events low and
similar to vehicle. Only 5 out of 200 subjects (2.5%) in the
roflumilast foam treated group discontinued the study due to an
adverse event, compared to 2 out of 104 subjects (1.9%) treated
with the vehicle.
“Scalp psoriasis inflicts a high burden for
patients, and current treatment options often carry significant
treatment limitations that result in poor outcomes and can have a
negative impact on patient quality of life,” said Leon Kircik, MD,
Clinical Professor of Dermatology, Icahn School of Medicine at
Mount Sinai, Indiana University Medical Center, and Medical
Director, Physicians Skin Care, DermResearch, and Skin Sciences.
“Roflumilast once-daily foam demonstrated rapid and significant
improvements in psoriasis signs and symptoms, including reducing
itch in a meaningful way. These positive results are encouraging
for patients and clinicians who are desperate for new treatments
that can simplify disease management, can be used in all areas of
the body, and can ultimately improve the patient experience.”
“Approximately 40 percent of the 6 million
Americans afflicted with active, chronic psoriasis have scalp
involvement, an area where treatment of scalp plaques is
complicated by the difficulty of delivering topical drugs under the
hair and to the surface of the skin,” said Linda F. Stein Gold, MD,
Director of Dermatology Clinical Research at Henry Ford Health
System in Detroit, Michigan, as well as Division Head of
Dermatology at Henry Ford Health System in West Bloomfield,
Michigan. “Novel treatments are needed, particularly ones like
topical roflumilast foam that have the potential to be safe for
chronic use; that are appropriate for application in hair-bearing
areas where a cream, lotion, or ointment is not suitable; and that
have demonstrated symptomatic improvement similar to high-potency
steroids while also maintaining a favorable safety and tolerability
profile. I believe these data demonstrate that once daily
roflumilast foam could offer patients the efficacy and tolerability
that they need. In my opinion, if approved, topical roflumilast
foam has the potential to become an important treatment option for
plaque psoriasis patients, particularly those with scalp
involvement.”
“We are delighted with these data, in which
topical roflumilast foam demonstrated meaningful symptomatic
improvement, alongside a favorable safety and tolerability profile
that supports chronic use,” said Patrick Burnett, M.D., Ph.D.,
FAAD, and Chief Medical Officer of Arcutis. “With once-a-day
dosing, roflumilast foam potentially offers the convenience of a
simple, single, non-steroidal solution for both scalp and non-scalp
plaques. If successful in Phase 3 clinical trials and approved for
commercialization, roflumilast foam will be the first novel
mechanism of action for the treatment of scalp and body psoriasis
in decades. We believe it has the potential to positively affect
the symptoms and quality of life of the millions of patients who
suffer from this distressing chronic skin condition.”
Management will host a conference call today at
8:30 a.m. EST to discuss these results. To access the call, please
dial (833) 614-1393 (domestic) or (914) 987-7114 (international)
prior to the scheduled conference call time and provide the
conference ID 8960956. A live webcast of the call will be available
on the "Investors" section of the company's website,
www.arcutis.com. An archived version of the webcast will be
available on the Arcutis website after the call.
About Roflumilast
FoamRoflumilast foam is a once-daily topical foam
formulation of a highly potent and selective phosphodiesterase type
4 inhibitor (PDE4 inhibitor) that Arcutis is developing
particularly to treat inflammatory dermatoses in hair-bearing areas
of the body such as the scalp.
Roflumilast has been approved by the 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.
Arcutis believes roflumilast foam has
significant potential as a treatment for scalp psoriasis and
seborrheic dermatitis. Roflumilast foam is nearly identical to
ARQ-151 (topical roflumilast cream), Arcutis’ investigational
topical cream PDE4 inhibitor that has demonstrated symptomatic
improvement and a favorable tolerability profile in Arcutis’
clinical trials in plaque psoriasis, as well as encouraging results
in atopic dermatitis. Arcutis completed enrollment in DERMIS-1 and
DERMIS-2, the Company’s pivotal Phase 3 clinical trials evaluating
topical roflumilast cream as a potential topical treatment for
plaque psoriasis, and the Company expects to announce topline data
in the first quarter of 2021 and to submit a New Drug Application
(NDA) submission by the end of 2021. In addition, following its
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA), Arcutis plans to advance its program to develop topical
roflumilast cream for the treatment of atopic dermatitis into Phase
3 clinical trials beginning in early 2021.
About Scalp PsoriasisScalp
psoriasis is a manifestation of plaque psoriasis characterized by
raised, red areas of skin (“plaques”) covered with a silver or
white scale that occurs in the hair-bearing area of the scalp and
sometimes extending to the forehead, back of the neck, or behind or
inside the ears. Patients with scalp psoriasis commonly have
plaques on other areas of the body as well. Approximately 40
percent of the estimated 8.6 million Americans with psoriasis have
involvement of the scalp, and over a lifetime, up to 80 percent of
psoriasis patients may experience scalp involvement. Scalp
psoriasis plaques are identical to psoriatic plaques on other areas
of the body; however, topical treatment of scalp plaques is
complicated by the difficulty of delivering topical drugs under the
hair and onto the skin. As with psoriatic plaques on other parts of
the body, psoriasis on the scalp is often itchy and is sometimes
painful. Scalp psoriasis can also be associated with hair loss,
likely due to damage to the hair from excessive scratching,
rubbing, or combing of the affected area. Often, patients require
two or more medications to manage their disease when they have
scalp involvement.
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 roflumilast foam’s potential as
a scalp and body psoriasis treatment and whether roflumilast
cream’s Phase 2 results may be predictive of roflumilast foam’s
potential clinical outcomes. 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.
Investor Contact:Heather Rowe
ArmstrongVice President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext.
740
A PDF accompanying this announcement is available
at http://ml.globenewswire.com/Resource/Download/d3d13839-6109-4c6c-a20c-b9bb48d2c612
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