Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced
positive topline results from its INTEGUMENT-2 pivotal Phase 3
trial of roflumilast cream 0.15%, a once-daily, non-steroidal
topical phosphodiesterase-4 (PDE4) inhibitor, in adults and
children 6 years and older with mild to moderate atopic
dermatitis (AD). The study met its primary endpoint, with
28.9% of individuals treated with roflumilast cream 0.15% achieving
IGA Success, defined as a validated Investigator Global Assessment
– Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’
plus a 2-grade improvement from baseline at Week 4, compared to
12.0% of individuals treated with vehicle (P<0.0001).
“Atopic dermatitis, a common condition in children through
adults, is a chronic disease characterized by intense, persistent
itching and eczematous rashes, that can greatly impact quality of
life,” explained Lawrence F. Eichenfield, MD, chief of pediatric
and adolescent dermatology at Rady Children's Hospital-San Diego,
professor of dermatology and pediatrics and vice-chair of the
department of dermatology at UC San Diego School of Medicine, and
study investigator. “Adults and children who suffer with atopic
dermatitis are in need of non-steroidal topical treatment options
that are safe, well-tolerated, and suitable for long-term use. The
strong results from this second pivotal Phase 3 trial, which are
consistent with the findings from INTEGUMENT-1, further reinforce
the safety and efficacy profile of roflumilast cream and its
potential as a new treatment option for atopic dermatitis.”
Roflumilast cream also demonstrated rapid and statistically
significant improvements compared to vehicle on key secondary
endpoints, including 42.0% of individuals treated with roflumilast
cream 0.15% achieving a 75% improvement in Eczema Area and Severity
Index (EASI-75) at Week 4 compared to 19.7% treated with vehicle
(P<0.0001).
In an additional secondary endpoint, the study evaluated
reduction in itch in individuals 12 years of age and older, with
30.2% of individuals treated with roflumilast cream achieving a
4-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week 4
(vs. 12.4% for vehicle-treated subjects [p<0.01]).
AD is the most common type of eczema, affecting approximately
9.6 million children and 16.5 million adults in the United States.
Topical therapies are an important treatment option for the
majority of individuals who use pharmaceuticals to treat their
disease.
“We are very pleased with these positive findings from
INTEGUMENT-2, our second of two Phase 3 pivotal trials with
roflumilast cream 0.15% in individuals with mild to moderate atopic
dermatitis aged 6 years and older. Roflumilast cream delivered
positive efficacy as early as Week 1 for symptomatic response in
itch and Week 2 for IGA Success, as well as favorable safety and
tolerability results,” said Patrick Burnett, MD, PhD, FAAD, chief
medical officer at Arcutis. “With these positive results, we plan
to move forward with filing a supplemental new drug application
(sNDA) with the United States Food & Drug Administration (FDA)
for roflumilast cream 0.15% for the treatment of mild to moderate
atopic dermatitis in adults and children 6 years of age and older
in the second half of 2023.”
“I am incredibly proud of the entire Arcutis team for their
ability to complete enrollment and report positive results for four
Phase 3 pivotal trials across three indications for topical
roflumilast in 2022. All of this is on the heels of the FDA
approval and successful launch of our first product in plaque
psoriasis,” said Frank Watanabe, president and CEO at Arcutis. “We
are also deeply grateful for all of the investigators and
individuals with atopic dermatitis, seborrheic dermatitis, and
scalp and body psoriasis who volunteered to enroll in these
trials.”
Roflumilast cream 0.15% was well tolerated. The incidence of
Treatment Emergent Adverse Events (TEAEs) was low in both active
treatment and vehicle arms, with most TEAEs assessed as mild to
moderate severity. Overall, incidence of adverse events were low,
with no adverse event occurring in more than 3.5% of subjects in
either arm. The most frequent adverse events in the roflumilast arm
(≥1%) included headache, nausea, vomiting, diarrhea, and upper
respiratory tract infection. Over 90% of patients who were
randomized to roflumilast cream in the study completed the full
four weeks, and there were few discontinuations due to adverse
events (1.8% and 0.9% in the roflumilast cream and vehicle groups,
respectively).
The Company will host a conference call to discuss the results
of both INTEGUMENT-1 and INTEGUMENT-2 today at 8:30 a.m. ET. A live
webcast of the call and the presentation material will be available
on the “Events” section of the Company’s investor website. An
archived replay of the webcast will be available on the Arcutis
investor website following the conference.
Summary of Topline Results from INTEGUMENT-1 and
INTEGUMENT-2Arcutis investigated roflumilast cream 0.15%
in adults and children aged 6 and over with mild to moderate AD in
two identical pivotal Phase 3 studies, INTEGUMENT-1 and
INTEGUMENT-2. In November, the company reported positive topline
findings from INTEGUMENT-1.
|
INTEGUMENT-1Week 4 |
INTEGUMENT-2Week 4 |
|
Roflumilastcream |
Vehicle |
P-value |
Roflumilastcream |
Vehicle |
P-value |
vIGA-AD |
32.0% |
|
15.2% |
|
P<0.0001 |
28.9% |
|
12.0% |
|
P<0.0001 |
EASI-75 |
43.2% |
|
22.0% |
|
P<0.0001 |
42.0% |
|
19.7% |
|
P<0.0001 |
WI-NRS |
33.6% |
|
20.7% |
|
P<0.01 |
30.2% |
|
12.4% |
|
P<0.01 |
About INTEGUMENT-2The
“INterventional Trial EvaluatinG roflUMilast cream for the
treatmENt of aTopic dermatitis” 2 (INTEGUMENT-2) is a Phase 3,
parallel group, double blind, vehicle-controlled trial in which
roflumilast cream 0.15% or vehicle is applied once daily for four
weeks to individuals 6 years of age and older with mild to moderate
AD involving ≥3% body surface area. A total of 683 individuals were
randomized in the study. The primary endpoint was IGA Success,
defined as vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade
improvement from baseline at Week 4. Multiple secondary endpoints
were also evaluated, including itch as measured by WI-NRS as well
as the proportion of subjects who attained at least a 75%
improvement in EASI-75 at Week 4.
After completing INTEGUMENT-1 and INTEGUMENT-2, individuals were
eligible to enroll in an open-label extension study
(INTEGUMENT-OLE) evaluating treatment with once-daily roflumilast
cream 0.15% for up to 12 months.
Arcutis is enrolling a third pivotal Phase 3 trial, the
“INterventional Trial EvaluatinG roflUMilast cream for the
treatmENt of aTopic dermatitis in PEDiatric patients”
(INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children 2
to 5 years of age with mild to moderate AD. The Company plans to
report topline data from this study in 2023.
About Atopic DermatitisAD is the most common
type of eczema, affecting approximately 9.6 million children and
16.5 million adults in the U.S. 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. The rash can cover significant areas
of the body, in some cases half of the body or more. AD typically
begins in early childhood and is chronic. It persists into
adolescence and even adulthood in some individuals. The rash causes
significant pruritus (itching), which can lead to skin damage
caused by scratching or rubbing. Since a large percentage of AD
patients are very young children, safety is a particularly
important consideration in treatment selection.
About Roflumilast Cream Roflumilast cream is a
next generation topical PDE4 inhibitor. PDE4 – an established
target in dermatology – 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. For AD, roflumilast cream is being evaluated at
lower doses: 0.15% for adults and children 6 years of age and
older, and 0.05% for children aged 2 to 5 years.
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is an early commercial-stage medical dermatology
company that champions meaningful innovation to address the urgent
needs of individuals living with immune-mediated dermatological
diseases and conditions. With a commitment to solving the most
persistent patient challenges in dermatology, Arcutis has a
growing portfolio that harnesses our unique dermatology
development platform coupled with our dermatology expertise to
build differentiated therapies against biologically validated
targets. Arcutis’ dermatology development platform includes a
robust pipeline with multiple clinical programs for a range of
inflammatory dermatological conditions
including scalp and body psoriasis, atopic
dermatitis, seborrheic dermatitis, and alopecia areata. For more
information, visit www.arcutis.com or follow Arcutis
on LinkedIn, Facebook, and Twitter.
Forward-Looking StatementsArcutis cautions you
that statements contained in this press release regarding matters
that are not historical facts are forward-looking statements. These
statements are based on the Company’s current beliefs and
expectations. Such forward-looking statements include, among
others, statements regarding the potential for roflumilast to be
approved for the treatment of adults and children with AD, the
potential to use roflumilast cream over a long period of time, or
chronically, the potential to use roflumilast cream anywhere on the
body, including the face and sensitive areas, timing for
anticipated data of INTEGUMENT-PED, the potential sNDA filing and
the potential for roflumilast to advance the standard of care in AD
and other inflammatory dermatologic conditions. These
statements are subject to 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. Risks and uncertainties that may cause
our actual results to differ include risks inherent in our
business, reimbursement and access to our products, the impact of
competition and other important factors discussed in the “Risk
Factors” section of our Form 10-K filed with U.S. Securities and
Exchange Commission (SEC) on February 22, 2022, as amended, as well
as any subsequent filings with the SEC. You should not place undue
reliance on any forward-looking statements in this press release.
We undertake no obligation to revise or update information herein
to reflect events or circumstances in the future, even if new
information becomes available. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Contacts:MediaAmanda Sheldon,
Head of Corporate Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@arcutis.com
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