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 topline data from its Phase 2 clinical trial evaluating
ARQ-154 (topical roflumilast foam) as a potential treatment for
seborrheic dermatitis.
Roflumilast foam 0.3% administered once daily
for 8 weeks demonstrated statistically significant improvement
compared to a matching vehicle foam on key efficacy endpoints in
subjects with moderate-to-severe seborrheic dermatitis. On the
study’s primary endpoint assessed at week 8, roflumilast foam 0.3%
achieved an Investigator Global Assessment (IGA) success rate of
73.8% compared to a vehicle rate of 40.9% (p<0.0001). IGA
success is defined as the achievement of an IGA score of 'clear' or
'almost clear' on a 5-grade scale PLUS at least a two-point change
from baseline. The onset of effect was rapid, with ARQ-154
statistically separating from vehicle as early as week 2, the first
visit after baseline, on IGA success as well as multiple secondary
endpoints. For example, at week 8, 64.6% of subjects treated with
roflumilast foam who had a baseline Worst Itch Numeric Rating Scale
(WI-NRS) score of 4 achieved an itch reduction of at least 4 points
compared to 34.0% of vehicle treated subjects (p=0.0007). Other
secondary endpoints included overall assessment of erythema and
overall assessment of scaling, which also had positive outcomes.
Importantly, roflumilast foam was well-tolerated, with rates of
application site adverse events, treatment-related adverse events,
and discontinuations due to adverse events low and similar to
vehicle. Only 2 out of 154 subjects (1.3%) treated with roflumilast
foam discontinued the study due to an adverse event, compared to 1
out of 72 subjects (1.4%) treated with the vehicle.
“Seborrheic dermatitis is one of the most common
skin conditions dermatologists deal with in adults, right up there
with acne, rosacea, psoriasis and eczema. It has an enormous effect
on patient’s lives because it is so visible and often embarassing,
with red, greasy, flaky areas on the face and scalp that are almost
impossible to hide. Making it even worse, many of the more than 10
million sufferers in the U.S. may not know what it is, thereby
contributing to the problem of under-treatment and inadequate
treatment of the disease,” said Matthew Zirwas, M.D., founder of
the Bexley Dermatology Research Clinic and an investigator in the
trial. “Current topical treatments for seborrheic dermatitis have
major limitations, either having low efficacy, such as with topical
antifungals, topical immunomodulators, low potency steroids and
prescription shampoos, or high efficacy but unacceptable side
effect profiles, such as with high potency topical steroids. Of the
major dermatologic diseases, it has the greatest need for new
treatment options. I believe these data demonstrate that once daily
roflumilast foam is well-tolerated and effective. In my opinion, if
approved, it has the potential to become the new standard of care
in seborrheic dermatitis.”
“We are delighted with the robust signal for the
efficacy of roflumilast foam in this relatively small, study. In
this trial, topical roflumilast foam demonstrated meaningful
symptomatic improvement, including a reduction in itch, 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 single, easy to use product
to treat seborrheic dermatitis in all body locations where a
patient might be affected. Unlike creams and ointments, roflumilast
foam is suitable for use in hair-bearing areas; unlike steroids, it
is expected to be suitable for long-term use on the face; and
unlike shampoos, it is an elegant, quick drying, leave-in foam that
doesn’t need to be rinsed out. If successful in Phase 3 clinical
trials and approved for commercialization, roflumilast foam will be
the first topical drug treatment in decades to offer a novel
mechanism of action for the treatment of seborrheic dermatitis, and
has the potential to positively affect the symptoms and quality of
life of patients who suffer from this distressing chronic skin
condition.”
Between December 2019 and June 2020, the Phase 2
trial enrolled 226 adult subjects with moderate-to-severe
seborrheic dermatitis. This 8-week, multi-center, multi-national,
double blind, vehicle-controlled study evaluated the safety and
efficacy of roflumilast foam 0.3% administered once-daily to
affected areas on the scalp, face, and body. Topline efficacy data,
including the primary endpoint, IGA success at week 8, were
analyzed using the population of all randomized subjects with the
exception of subjects who missed the week 8 IGA assessment
specifically due to COVID-19 disruption. Importantly, only two
subjects missed the week 8 IGA assessment due to concerns arising
from COVID-19, and therefore the Intent-to-Treat (ITT) and modified
ITT populations differed by only two subjects. Arcutis expects to
present the full results from the trial at a future medical
conference.
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 7378204. 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.
Roflumilast 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 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 late 2020 or early 2021.
In addition to this Phase 2 trial, Arcutis is
also conducting a Phase 2 long-term safety study in seborrheic
dermatitis. This is a multicenter, open-label study of roflumilast
foam 0.3% applied once daily in patients with seborrheic dermatitis
and will include patients who were treated previously in the Phase
2 trial, as well as patients naïve to treatment with topical
roflumilast foam. Periodic clinic visits will include assessments
for clinical safety, application site reactions, and disease
improvement, or progression.
About Seborrheic
DermatitisSeborrheic dermatitis affects more than 10
million people in the U.S., and is a common, chronic or recurrent
inflammatory skin disease that causes red patches covered with
large, greasy, flaking yellow-gray scales, and persistent itch.
Seborrheic dermatitis occurs most often on the scalp, face
(especially on the nose, eyebrows, ears, and eyelids), upper chest
and back.
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 ARQ-154’s potential as a seborrheic dermatitis treatment;
the Company’s expectation to present the full results from the
seborrheic dermatitis trial at a future medical conference; the
Company’s plan to announce ARQ-151 topline data for plaque
psoriasis in the first quarter of 2021 and to submit a New Drug
Application (NDA) submission by the end of 2021; the Company’s plan
to initiate pivotal Phase 3 clinical trials for ARQ-151 in atopic
dermatitis in late 2020 or early 2021. 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.
Investor
Contact:Heather Rowe
ArmstrongVice President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
Media Contact:Mike BeyerSam Brown Inc.
Healthcare
Communicationsmikebeyer@sambrown.com312-961-2502
A PDF accompanying this announcement is available
at http://ml.globenewswire.com/Resource/Download/630458c3-2f79-40cc-8260-2ef350559bbd
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