Arcutis Initiates Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for...
14 January 2021 - 1:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology
company developing innovative treatments for patients with
immune-mediated dermatological diseases and conditions, today
announced that it has commenced pivotal Phase 3 clinical trials
evaluating topical roflumilast cream (ARQ-151) as a potential
treatment for atopic dermatitis (AD). Roflumilast cream is a once
daily topical formulation of roflumilast, a highly potent and
selective phosphodiesterase type 4 inhibitor (PDE4), which the
Company is developing for plaque psoriasis and AD.
“More than 19 million people in the U.S. suffer
from atopic dermatitis, of which at least 60 percent are young
children, thereby making safety and tolerability particularly
important in this disease,” said Patrick Burnett, M.D., Ph.D.,
FAAD, Arcutis’ Chief Medical Officer. “Atopic dermatitis is
characterized by a defect in the skin barrier, which results in a
red, itchy rash that in many cases can cover significant areas of
the body. Current treatments often fall short, resulting in
patients, parents and physicians having to make trade-offs between
efficacy, safety and tolerability.”
Dr. Burnett continued, “We are excited to begin
our pivotal Phase 3 trials in patients with atopic dermatitis. If
approved, roflumilast cream would be the first once-a-day topical
nonsteroidal treatment for AD, and would also offer patients a
cosmetically-elegant, non-greasy formulation. In clinical trials,
roflumilast cream has demonstrated a benign safety and tolerability
profile, without the local tolerability or safety issues associated
with many other topical AD treatments, and importantly, unlike
steroids, it can safely be used chronically. We believe topical
roflumilast has the potential to eliminate the need to compromise
between safety, efficacy, and tolerability, and we look forward to
reporting topline data in the second half of 2022.”
The “INterventional Trial EvaluatinG roflUMilast
cream for the treatmENt of aTopic dermatitis” 1 and 2 (or
INTEGUMENT-1 and -2) are identical Phase 3, parallel group, double
blind, vehicle-controlled trials in which roflumilast cream 0.15%
or vehicle is applied once daily for 4 weeks to subjects 6 years of
age and older with mild to moderate AD involving ≥3% body surface
area.
In each trial, approximately 650 subjects are
planned to be randomized 2:1 to either roflumilast cream 0.15% or
matching vehicle cream. The primary endpoint of both trials is
Investigator Global Assessment (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. Multiple secondary endpoints
will also be evaluated, including itch as measured by the Worst
Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of
subjects who attain at least a 75% reduction in the Eczema Area and
Severity Index (EASI-75) at Week 4. After completing INTEGUMENT-1
or -2, subjects may be eligible to enroll in a 12‑month, open label
extension study (INTEGUMENT-OLE) evaluating once daily roflumilast
cream. The Company anticipates topline data from INTEGUMENT-1 and
-2 in the second half of 2022.
Arcutis also plans to initiate a third pivotal
Phase 3 study, the “INterventional Trial EvaluatinG roflUMilast
cream for the treatmENt of aTopic dermatitis in PEDiatric patients”
(or INTEGUMENT-PED) shortly to evaluate roflumilast cream in
subjects 2 to 5 years of age with mild to moderate AD.
About Atopic DermatitisAtopic
dermatitis (AD) is the most common type of eczema, occurring in
approximately 6% 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 is paramount.
About Topical Roflumilast CreamRoflumilast
Cream is a topical cream formulation of a highly potent and
selective PDE4 inhibitor (roflumilast). Roflumilast has been
approved by the U.S. Food and Drug Administration (FDA) for oral
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.
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
https://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 cream’s potential as a treatment
for atopic dermatitis; and expectations with regard to the timing
of clinical data anticipated in the second half of 2022. 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.
Investors and Media:Heather Rowe ArmstrongVice
President, Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
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