Arcutis Enrolls First Patient in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Scalp and Body Psoriasis
August 25 2021 - 8:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing meaningful
innovations to address the urgent needs of patients living with
immune-mediated dermatological diseases and conditions, or
immuno-dermatology, today announced it had enrolled the first
patient in its single Phase 3 clinical trial evaluating topical
roflumilast foam (ARQ-154) as a potential treatment for scalp and
body psoriasis. Roflumilast foam is a once-daily topical foam
formulation of roflumilast, a highly potent and selective
phosphodiesterase type 4 (PDE4) inhibitor, which the Company is
developing for both seborrheic dermatitis and scalp and body
psoriasis.
“The symptoms of scalp and body psoriasis,
including itch and pain, can negatively impact quality of life for
the millions of Americans affected. One challenge for patients with
scalp psoriasis is that they often require two or more medications
for different areas of the body to manage their disease,” said
Patrick Burnett, Ph.D., M.D., FAAD, Chief Medical Officer of
Arcutis. “In our previous Phase 2b trial, roflumilast foam was
demonstrated to be a safe, well-tolerated, and effective potential
treatment for scalp and body psoriasis. We are pleased to initiate
this Phase 3 trial, as we believe roflumilast foam, if approved,
may represent a much-needed, new standard of care for people with
scalp and body psoriasis that is suitable for use in hair-bearing
areas, unlike creams and ointments, and does not pose the safety
concerns typically seen with topical steroids.”
The “A Randomized
tRial Employing
topiCal roflumilasT foam to treat
scalp psORiasis” (ARRECTOR) study is a parallel
group, double blind, vehicle-controlled pivotal Phase 3 study of
the safety and efficacy of ARQ-154 0.3% foam or a matching vehicle
administered once-daily in approximately 420 subjects with scalp
and body psoriasis ages 12 and older. The co-primary endpoints of
the study include the proportion of subjects achieving
Scalp-Investigator’s Global Assessment (IGA) success and the
proportion of subjects achieving Body-IGA success, with IGA success
defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point
improvement from baseline after eight weeks. Based on prior
discussions with the U.S. Food and Drug Administration (FDA), the
Company believes that, if successful, this trial will provide
sufficient basis to file a supplemental NDA for ARQ-154 in scalp
and body psoriasis.
“Our aim at Arcutis is to rapidly innovate topical
treatments for dermatological conditions where there has been
little to no treatment advances for decades. The initiation of our
Phase 3 trial of roflumilast foam for scalp and body psoriasis is
an important step forward to addressing an urgent unmet need,” said
Frank Watanabe, President and Chief Executive Officer at Arcutis.
“The initiation of our ARRECTOR trial is the third of three new
Phase 3 programs initiated in 2021 with readouts expected in 2022
and highlights the robustness of our unique dermatology drug
development platform.”
About Scalp and Body
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 Topical Roflumilast Foam
Topical roflumilast foam is a once-daily, topical formulation of a
highly potent and selective PDE4 inhibitor (roflumilast). The
unique foam formulation is designed to penetrate and treat
inflammatory dermatoses in hair-bearing areas of the body, such as
the scalp, although it is usable on all areas of the body.
Roflumilast has been approved by the FDA for oral treatment to
reduce the risk of exacerbations of chronic obstructive pulmonary
disease (COPD) since 2011. In Phase 3 trials, topical roflumilast
cream (ARQ-151) has previously been demonstrated to be a safe,
well-tolerated, and effective potential treatment for plaque
psoriasis, and Arcutis expects to file an NDA with the FDA for
roflumilast cream in late Q3 or early Q4 2021. Roflumilast has
shown greater potency (25- to 300-fold) than the two other
FDA-approved PDE4 inhibitors for dermatology. 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, atopic dermatitis,
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 and the systemic treatment of plaque
psoriasis.
About ArcutisArcutis
Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology
company that champions meaningful innovation to address the urgent
needs of patients living with immune-mediated dermatological
diseases and conditions. With a commitment to solving the most
persistent patient challenges in dermatology, Arcutis 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 seven clinical
programs for a range of inflammatory dermatological conditions,
with our first NDA submission anticipated by the end of 2021 and
three more Phase 3 clinical data readouts anticipated over the next
18 months. The company’s lead product candidate, topical
roflumilast, has the potential to advance the standard of care for
plaque psoriasis, atopic dermatitis, scalp psoriasis, and
seborrheic dermatitis. For more information,
visit www.arcutis.com or follow Arcutis
on LinkedIn and Twitter.
Forward-Looking StatementsThis
press release contains "forward-looking" statements, including,
among others, statements regarding the potential for roflumilast to
revolutionize the standard of care in plaque psoriasis and other
inflammatory dermatological conditions. 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-K filed with U.S. Securities and Exchange Commission (SEC)
on February 16, 2021, 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.
Contacts:
MediaAmanda Sheldon, Head of
Corporate Communications1 805-418-5006asheldon@arcutis.com
InvestorsEric McIntyre, Head of
Investor Relations1 805-418-5006emcintyre@arcutis.com
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